Adapalene gel 0.1% is effective and safe for Japanese patients with acne vulg... Related Articles Adapalene gel 0.1% is effective and safe for Japanese patients with acne vulgaris: A randomized, multicenter, investigator-blinded, controlled study. J Dermatol Sci. 2007 Dec 4; Authors: Kawashima M, Harada S, Loesche C, Miyachi Y BACKGROUND: Topical retinoids, such as adapalene, are an integral part of acne therapy in most regions and are considered appropriate first-line therapy by international guidelines for all cases of acne with the exception of the most severe. However, there are currently no topical retinoids available for the treatment of acne vulgaris in Japan. OBJECTIVE: To confirm efficacy and safety of adapalene gel 0.1% versus the corresponding gel vehicle in the treatment of Japanese patients with acne vulgaris for up to 12 weeks. METHODS: A total of 200 patients were randomized to receive adapalene gel 0.1%, or vehicle once-daily for 12 weeks. Percent reduction in lesion counts (total, inflammatory, and non-inflammatory) and subject satisfaction were evaluated. Safety was monitored through adverse events and laboratory tests. RESULTS: Adapalene gel 0.1% produced significantly better reductions in total (P<0.0001), inflammatory (P=0.0010), and non-inflammatory lesions (P<0.0001) at endpoint (week 12, last observation carried forward) than gel vehicle, with a higher overall subject satisfaction. The primary efficacy variable, the median percent reduction of total lesion counts at endpoint, was significantly greater with adapalene gel 0.1% (63.2%) compared to that with the vehicle (36.9%) in the ITT population (P<0.0001). Significantly greater results were observed as early as week 1. Adapalene was well tolerated, with adverse events that were mostly mild-to-moderate and transient in nature. CONCLUSIONS: Adapalene gel 0.1% was effective in the treatment of acne vulgaris in Japanese patients. Adapalene was safe and well tolerated, consistent with the good tolerability profile demonstrated in other patient populations. PMID: 18063345 [PubMed - as supplied by publisher] A randomized, single-blind comparison of topical clindamycin + benzoyl peroxi... Related Articles A randomized, single-blind comparison of topical clindamycin + benzoyl peroxide and adapalene in the treatment of mild to moderate facial acne vulgaris. Br J Dermatol. 2008 Jan;158(1):122-9 Authors: Langner A, Chu A, Goulden V, Ambroziak M Background Antibiotics are often combined with other agents to provide topical acne treatments that are effective against both inflammatory and noninflammatory lesions and minimize the development of antibiotic resistance. Retinoids and associated treatments also have anti-inflammatory activity and decrease microcomedo formation. To date, few direct comparisons of these different acne treatments have been conducted. Objectives To compare the clinical effectiveness of two treatments for facial acne: a ready-mixed once-daily gel containing clindamycin phosphate 10 mg mL(-1) + benzoyl peroxide 50 mg mL(-1) (CDP + BPO; Duac((R)); Stiefel, High Wycombe, U.K.) and a once-daily gel containing adapalene 0.1% (ADA; Differin((R)); Galderma, Watford, U.K.). Methods In this assessor-blind, randomized study; 65 patients were treated with CDP + BPO once daily and 65 patients with ADA once daily. The treatment period was 12 weeks and lesion counts, acne grade and global improvement were assessed at weeks 1, 2, 4, 8 and 12. Results CDP + BPO showed an earlier onset of action with a faster significant reduction in inflammatory and total lesion counts than ADA. A between-group comparison of the percentage change from baseline showed that CDP + BPO was statistically significantly superior to ADA from week 1 onwards both for inflammatory lesions (P </= 0.001) and for total lesions (P </= 0.004). While 76% of inflammatory lesions remained at week 2 for patients using ADA, in contrast, only 55% of inflammatory lesions remained at week 2 in the CDP + BPO group, resulting in a treatment effect of 1.38. Thus CDP + BPO removed 38% more inflammatory lesions than ADA at this timepoint. The trend in favour of CDP + BPO, although less marked, continued to the end of the study. CDP + BPO was better tolerated than ADA, with a greater proportion of ADA-treated patients experiencing treatment-related adverse events. Adjunctive topical or oral agents and their impact on acne were not studied in this trial. Due to product differences, this study could not be double blinded but was only single (assessor) blinded. Conclusions CDP + BPO and ADA are both effective treatments for acne, but CDP + BPO has a significantly earlier onset of action, is significantly more effective against inflamed and total lesions and is better tolerated, which should improve patient compliance. PMID: 18047518 [PubMed - in process] Differin (adapalene) Gel, 0.3%. Related Articles Differin (adapalene) Gel, 0.3%. Skinmed. 2007 Nov-Dec;6(6):287-8 Authors: Abramovits W, Gupta A PMID: 17975346 [PubMed - in process] Combining clindamycin 1%-benzoyl peroxide 5% gel with multiple therapeutic op... Related Articles Combining clindamycin 1%-benzoyl peroxide 5% gel with multiple therapeutic options. Cutis. 2006 Aug;78(2 Suppl 1):13-20 Authors: Bikowski J, Callender VD, Del Rosso JQ, Draelos ZD, Tanghetti E This article reports on recent studies and case reports that evaluated the stability, tolerability, and efficacy of clindamycin 1%-benzoyl peroxide 5% tube gel in combination with topical retinoids and oral antibiotics. Overall, these combinations appeared to be well-tolerated, effective, and, as reported in the case studies, adaptable to common clinical practice. PMID: 17966495 [PubMed - indexed for MEDLINE] Combination topical therapy in the treatment of acne. Related Articles Combination topical therapy in the treatment of acne. Cutis. 2006 Aug;78(2 Suppl 1):5-12 Authors: Del Rosso JQ Many medications are available for the management of acne. The armamentarium includes topical retinoids (ie, adapalene, tazarotene, tretinoin), antimicrobial and antibacterial agents (ie, benzoyl peroxide, clindamycin, erythromycin, sulfacetamide with or without sulfur), oral antibiotics (ie, doxycycline, minocycline, tetracycline), hormonal agents (ie, oral contraceptives, spironolactone), and systemic retinoids (ie, isotretinoin). Acne usually is treated with combination therapy to address its multifactorial pathophysiology. The combination of clindamycin 1%-benzoyl peroxide 5% gel, available as a stable formulation in a single tube, is efficacious and well-tolerated. The product's excipients, glycerin and dimethicone, minimize treatment-related irritation, thereby increasing patient compliance. Clindamycin-benzoyl peroxide may be well-tolerated when applied with topical retinoids, creating a more targeted and complete treatment strategy. PMID: 17966494 [PubMed - indexed for MEDLINE] Long-term safety and efficacy of a unique fixed-dose combination gel of adapa... Related Articles Long-term safety and efficacy of a unique fixed-dose combination gel of adapalene 0.1% and benzoyl peroxide 2.5% for the treatment of acne vulgaris. J Drugs Dermatol. 2007 Sep;6(9):899-905 Authors: Pariser DM, Westmoreland P, Morris A, Gold MH, Liu Y, Graeber M BACKGROUND: A unique, once-daily, fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BP) 2.5% has been developed for the treatment of acne vulgaris. OBJECTIVE: To evaluate the long-term (up to 12 months) safety and efficacy of the adapalene 0.1%/BP 2.5% fixed-dose combination gel for the treatment of acne vulgaris. METHODS: A total of 452 subjects were enrolled in this 12-month study and received adapalene/BP once daily. Evaluations included lesion count reduction, subject's assessment of acne, adverse events, and cutaneous tolerability. RESULTS: Adverse events were mild to moderate, occurred early in the study, and decreased thereafter. Discontinuations due to adverse events were low (2.0%) and no subjects discontinued due to lack of efficacy. Early and sustained reductions in inflammatory and noninflammatory lesions were observed, with clinically significant lesion reductions as early as week 1. CONCLUSIONS: These findings are consistent with previous clinical findings and support the use of a once-daily adapalene/BP fixed-dose combination as a safe and effective treatment in the long-term management of acne. PMID: 17941361 [PubMed - in process] Adapalene pretreatment increases follicular penetration of clindamycin: in vi... Related Articles Adapalene pretreatment increases follicular penetration of clindamycin: in vitro and in vivo studies. Indian J Dermatol Venereol Leprol. 2007 Sep-Oct;73(5):326-9 Authors: Jain GK, Ahmed FJ BACKGROUND: Topical retinoids normalize desquamation, reduce comedogenesis and may enhance the penetration of other topicals providing more effective treatment of acne. AIM: We evaluated the effect of adapalene on skin penetration of clindamycin phosphate when it is applied concomitantly or after various time durations following adapalene application. METHODS: The in vitro studies were carried out using excised rat skin, whereas the in vivo studies were conducted on healthy human volunteers. Radioactive clindamycin phosphate (1%) gel was applied to rat skin sections and to the hands of human volunteers concomitantly and after the pretreatment of the skin for 3, 5 and 10 min with 10 mg of adapalene (0.1%) gel. Quantification of clindamycin phosphate was performed by liquid scintillation. RESULTS: In vitro skin penetration and distribution of clindamycin phosphate was affected by the pretreatment time. Significantly higher skin concentration of clindamycin phosphate (15.5%) with largest proportion in viable skin layer (9.4% of applied dose) was found when clindamycin phosphate gel was applied after the pretreatment of the skin with adapalene gel for 5 min. Further increase in pretreatment time has no additive influence on the penetration of clindamycin phosphate. In vivo results were in corroboration with the in vitro results and demonstrate significantly higher concentration of clindamycin phosphate (19%) in the skin following pretreatment with adapalene gel for 5 min. Adapalene acts as a penetration enhancer and increases the penetration of topical clindamycin phosphate. CONCLUSION: Application of clindamycin phosphate gel after the pretreatment of skin with adapalene gel for 5 min may contribute significantly to the increased efficacy of therapy. PMID: 17921613 [PubMed - indexed for MEDLINE] Utilizing combination therapy for ethnic skin. Related Articles Utilizing combination therapy for ethnic skin. Cutis. 2007 Jul;80(1 Suppl):15-20 Authors: Taylor SC A major issue in treating acne in individuals of color is the need to treat and prevent postinflammatory hyperpigmentation (PIH), which is common in this population. This subset analysis reports the pigmentary changes in subjects of color with acne who were enrolled in a community-based trial comparing 3 different topical therapeutic regimens. All subjects received combination clindamycin 1%-benzoyl peroxide (BPO) 5% topical gel containing glycerin and dimethicone. Subjects were randomized to receive this combination therapy in addition to either a tretinoin microsphere (RAM) gel at concentrations of either 0.04% or 0.1% or adapalene (AP) gel 0.1%. There was a trend toward better resolution of hyperpigmentation in the subjects receiving the clindamycin-BPO topical gel in combination with RAM gel 0.04%. PMID: 17824582 [PubMed - indexed for MEDLINE] Community-based trial results of combination clindamycin 1%--benzoyl peroxide... Related Articles Community-based trial results of combination clindamycin 1%--benzoyl peroxide 5% topical gel plus tretinoin microsphere gel 0.04% or 0.1% or adapalene gel 0.1% in the treatment of moderate to severe acne. Cutis. 2007 Jul;80(1 Suppl):10-4 Authors: Kircik L Acne is characterized by different types of lesions at different stages of development. Therefore, combination therapy may offer numerous advantages, including enhanced efficacy and better tolerability. The addition of benzoyl peroxide (BPO) to all long-term antibiotic treatment is widely advocated to help suppress the emergence of antibiotic-resistant bacteria. Topical retinoids are recommended as early initiation treatment of most patients with acne because they target most mechanisms of acne pathogenesis. In the clinical setting, therapeutic regimens that include retinoids and topical antibiotic-BPO combination formulations frequently are prescribed. This study investigated the efficacy and safety of combination therapy with clindamycin 1%-BPO 5% topical gel plus tretinoin microsphere (RAM) gel 0.04% or 0.1% or adapalene (AP) gel 0.1% in moderate to severe acne. PMID: 17824581 [PubMed - indexed for MEDLINE] Novel Beads Made of Alpha-cyclodextrin and Oil for Topical Delivery of a Lipo... Related Articles Novel Beads Made of Alpha-cyclodextrin and Oil for Topical Delivery of a Lipophilic Drug. Pharm Res. 2007 Aug 2; Authors: Trichard L, Delgado-Charro MB, Guy RH, Fattal E, Bochot A PURPOSE: To investigate the potential of a novel lipid carrier, comprising beads of alpha-cyclodextrin and soybean oil, for topical drug delivery. Adapalene was chosen as a model drug to explore the ability of the beads to encapsulate and release a highly lipophilic compound. MATERIALS AND METHODS: Adapalene-loaded beads were prepared and characterised. Skin tolerance to unloaded beads was tested on human volunteers, while drug release and delivery into stratum corneum, was evaluated in pig skin ex vivo. RESULTS: The preparation and physical characteristics of the beads were not dependent on whether adapalene had been previously dissolved or dispersed in soybean oil. Drug encapsulation efficiency was high (>96%) and drug loading on the order of a therapeutic level could be achieved in freeze-dried beads prepared from an oily dispersion of adapalene. After application to human skin, unloaded beads induced no adverse reaction and were better tolerated than an alcoholic gel. Tape-stripping the stratum corneum from treated pig skin showed that adapalene release and penetration from the beads was comparable to that from gel and cream formulations available on the market. CONCLUSION: These novel beads may offer a well-tolerated and efficient system for the encapsulation and topical delivery of lipophilic drugs. PMID: 17671830 [PubMed - as supplied by publisher] Tolerability comparison of adapalene gel, 0.3% versus tazarotene cream, 0.05%... Related Articles Tolerability comparison of adapalene gel, 0.3% versus tazarotene cream, 0.05% in subjects with healthy skin. J Drugs Dermatol. 2007 Jun;6(6):632-8 Authors: Dosik JS, Arsonnaud S BACKGROUND: Topical retinoids, including adapalene and tazarotene, are a primary treatment choice for patients with acne. Adapalene is currently marketed in a 0.1% concentration in gel and cream formulation. A new gel containing a higher concentration (0.3%) of adapalene has been developed. In clinical studies, adapalene 0.1% concentration has proven to be better tolerated than other retinoids in skin treatment. However, the tolerability of adapalene gel 0.3% has yet to be compared to other topical retinoids. PURPOSE: The purpose of this study was to compare the local cutaneous tolerability of adapalene gel 0.3% once daily versus tazarotene cream 0.05% once daily. METHODS: Subjects reported to the investigative site each day Monday through Friday, cleansed the faced and then applied adapalene 0.3% gel to one side of the face and tazarotene 0.05% cream to the other in the presence of study personnel. For the weekends, subjects were instructed to apply the treatment at home according to the same procedure. Tolerability was assessed during each weekday visit. The study lasted for 3 weeks. RESULTS: Tolerability results for adapalene 0.3% gel and tazarotene 0.05% cream were statistically similar throughout the study. Investigator-assessed overall tolerability was in favor of adapalene at days 19 and 22 (P=.043). A cosmetic acceptability survey also showed results were better for adapalene 0.3% gel. CONCLUSION: Adapalene gel 0.3% is very well-tolerated with good cosmetic acceptability. PMID: 17668529 [PubMed - indexed for MEDLINE] Study results of benzoyl peroxide 5%/clindamycin 1% topical gel, adapalene 0.... Related Articles Study results of benzoyl peroxide 5%/clindamycin 1% topical gel, adapalene 0.1% gel, and use in combination for acne vulgaris. J Drugs Dermatol. 2007 Jun;6(6):616-22 Authors: Del Rosso JQ Combination therapy is the standard of care in the management of acne vulgaris. It is essential to treat as many aspects of acne pathogenesis as possible. Due to increasing insensitivity of Propionibacterium acnes to antibiotics, the concomitant use of other topical agents that exhibit other modes of antibacterial and anti-inflammatory activity is integral to the successful treatment of acne. The combination of topical benzoyl peroxide and clindamycin gel has been shown to be more effective than either agent alone. The addition of a topical retinoid may further enhance therapeutic results. This 12-week study evaluated the safety and efficacy of initial topical benzoyl peroxide 5%/clindamycin 1% gel as monotherapy and in combination with adapalene gel versus adapalene gel monotherapy in the management of acne. PMID: 17668527 [PubMed - indexed for MEDLINE] Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acn... Related Articles Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acne vulgaris: results of a multicenter, randomized double-blind, controlled study. J Am Acad Dermatol. 2007 Nov;57(5):791-9 Authors: Thiboutot DM, Weiss J, Bucko A, Eichenfield L, Jones T, Clark S, Liu Y, Graeber M, Kang S, BACKGROUND: A fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% has been developed for the once-daily treatment of acne. OBJECTIVE: To evaluate the efficacy and safety of adapalene 0.1% -BPO 2.5% fixed combination gel (adapalene-BPO) for the treatment of acne. METHODS: A total of 517 subjects were randomized in a double-blind controlled trial to receive either adapalene-BPO, adapalene, BPO, or vehicle for 12 weeks (2:2:2:1 randomization). Evaluation included success rate (subjects "clear" or "almost clear"), lesion count, cutaneous tolerability, and adverse events. RESULTS: The fixed-dose combination gel of adapalene and BPO was significantly more effective than corresponding monotherapies, with significant differences in total lesion counts observed as early as 1 week. Adverse event frequency and cutaneous tolerability profile for adapalene-BPO were similar to adapalene monotherapy. LIMITATIONS: These data were generated in a controlled trial. Results obtained in clinical practice could differ. CONCLUSIONS: The fixed-dose combination of adapalene and BPO provides significantly greater efficacy for the treatment of acne vulgaris as early as week 1 relative to monotherapies, with a comparable safety profile to adapalene. PMID: 17655969 [PubMed - indexed for MEDLINE] Safety and efficacy of adapalene gel 0.1% in acne vulgaris: results of a post... Related Articles Safety and efficacy of adapalene gel 0.1% in acne vulgaris: results of a post-marketing surveillance study. Indian J Dermatol Venereol Leprol. 2003 Jul-Aug;69(4):277-80 Authors: Percy SH INTRODUCTION: Adapalene is a novel retinoid indicated for the topical treatment of acne vulgaris. The drug was introduced in India in 2001. Aims: A post-marketing surveillance study was conducted to assess the safety and efficacy of adapalene gel 0.1% when used as monotherapy or in combination with other anti-acne agents in Indian patients of acne vulgaris. MATERIAL AND METHODS: A 12-week, multicentre, open-label, non-comparative study involving 571 patients from 21 centers across India was conducted between January and September of 2002. Concomitant prescription of other anti-acne drugs was permitted, if needed. RESULTS: Of the 571 patients, 441 completed the treatment as per protocol. At the end of therapy, 96.3% of patients showed an improvement in their acne from baseline, with greater than 75% improvement seen in two-thirds of patients. Adverse events were reported in 24% of the patients, none of which were serious. The tolerability of therapy was rated as excellent/good in 81% of patients by physicians and in 78% by the patients. CONCLUSION: Adapalene gel 0.1% is a safe and effective topical agent in the treatment of mild to moderate acne vulgaris in Indian patients. It may be safely combined with other topical and oral anti-acne agents. PMID: 17642911 [PubMed] Control of microcomedone formation throughout a maintenance treatment with ad... Related Articles Control of microcomedone formation throughout a maintenance treatment with adapalene gel, 0.1%. J Eur Acad Dermatol Venereol. 2007 Jul;21(6):747-53 Authors: Thielitz A, Sidou F, Gollnick H BACKGROUND: Microcomedones representing the clinically non-visible central precursor lesions of acne are induced by sebaceous hyperplasia as well as altered follicular growth and differentiation, and evolve into both comedones and inflammatory lesions. Thus, targeting microcomedone formation is essential in the prevention and therapeutic control of acne. OBJECTIVE: The aim of this study was to assess the capacity of adapalene gel, 0.1%, to control the number of microcomedones after a combination treatment followed by a maintenance treatment. METHODS: This was a single-site exploratory study in subjects with a diagnosis of mild to moderate acne vulgaris and the presence of at least 250 microcomedones per cm(2) at screening visit, counted via cyanoacrylate strips (CyASt). During the first 8 weeks, a combination of adapalene gel (0.1%) and benzoyl peroxide gel (2.5%) was applied. During the randomized, investigator-blinded, and vehicle-controlled 12-week maintenance phase, adapalene once daily (QD), or adapalene alternately with its vehicle once daily every other day (QoD), or vehicle QD were applied to the face. CyASt sampling on the forehead was done at baseline, week 8, and week 20. Lesion counting allowing calculating a defined success rate was done at all visits. RESULTS: A total of 54 subjects entered the combination phase, and 49 subjects were randomized into the maintenance phase: 16 in both the adapalene QD and the QoD group and 17 subjects receiving the vehicle. The microcomedone median count decreased for all groups until week 8 (end of combination phase) from 319 to 157. Microcomedone counts at the end of the maintenance phase (week 20) showed a significant percent difference (P = 0.04) between adapalene QoD (-53.5) and the vehicle (-42.1) and between adapalene QD (-50.6) and the vehicle (P = 0.037) compared with baseline. CONCLUSION: The application of adapalene gel, 0.1% monotherapy daily, or alternately every other day, significantly helps to control the microcomedone count during a 12-week maintenance treatment after a previous combination therapy with benzoyl peroxide in patients with mild to moderate acne. PMID: 17567301 [PubMed - indexed for MEDLINE] Clinical and microbiological comparisons of isotretinoin vs. tetracycline in ... Related Articles Clinical and microbiological comparisons of isotretinoin vs. tetracycline in acne vulgaris. Acta Derm Venereol. 2007;87(3):246-54 Authors: Oprica C, Emtestam L, Hagstr&#xF6;mer L, Nord CE The aim of this study was to compare the clinical and microbiological effect on Propionibacterium acnes of oral tetracycline plus topical adapalene vs. oral isotretinoin in moderate to severe acne vulgaris. Male and female acne patients with moderate or severe inflammatory disease were enrolled and assigned randomly to 6 months of treatment with oral tetracycline hydrochloride plus topical adapalene, or oral isotretinoin, in a controlled, open study. After cessation of oral treatment the antibiotic-treated group received topical adapalene for the 2-month follow-up period. Clinical and microbiological assessments were performed. Skin samples for microbial identification and quantification were taken at baseline, after 2, 4 and 6 months of treatment, and 2 months after cessation of treatment. Patients treated with isotretinoin showed prolonged significant remission compared with the other group. The density of resistant propionibacteria did not change significantly in any of the groups and there was no correlation between resistant P. acnes and the clinical response in any of the regions investigated. Antibiotic treatment was found to be a good alternative to isotretinoin, regardless of the presence of antibiotic-resistant P. acnes, although isotretinoin had a better effect, with prolonged remission after treatment. PMID: 17533492 [PubMed - indexed for MEDLINE] In vitro modulation of TLR-2, CD1d and IL-10 by adapalene on normal human ski... Related Articles In vitro modulation of TLR-2, CD1d and IL-10 by adapalene on normal human skin and acne inflammatory lesions. Exp Dermatol. 2007 Jun;16(6):500-6 Authors: Tenaud I, Khammari A, Dreno B The anti-inflammatory mechanisms of adapalene, a synthetic retinoid used for the treatment of acne patients, are partially understood. They seem particularly related to the modulation of the non-specific immunity. Recent studies have shown that Toll-like receptor (TLR)-2 expression, a receptor of the innate immune system, was increased in acne lesions and could play an essential role in acne-linked inflammation. The aim of our study was to investigate the new mechanisms of the anti-inflammatory activity of adapalene in vitro, and more specifically the modulatory effect of adapalene on the expression of TLR-2, CD1d, a cell surface glycoprotein that plays a role as antigen-presenting molecules and is responsible for the development of cutaneous inflammation, and also on the expression and the secretion of the anti-inflammatory interleukin (IL)-10 cytokine. Both explants of normal human skin and explants of acne patients were incubated with adapalene (10(-7) or 10(-6) M) or the control medium for 24 h. Evaluation of epidermal expression by immunohistochemistry showed a decreased expression of TLR-2 and IL-10 in explants of normal skin and explants of acne with adapalene. On the contrary, adapalene increased CD1d expression in explants of acne patients. Thus, adapalene can modulate the epidermal immune system by increasing the CD1d expression and by decreasing the IL-10 expression by keratinocytes. Moreover, these modulations could increase the interactions between dendritic cells and T lymphocytes and could strengthen the antimicrobial activity against Propionibacterium acnes. The decreased expression of TLR-2 by the keratinocytes can contribute to explain the anti-inflammatory activity of adapalene observed in clinical practice. PMID: 17518990 [PubMed - indexed for MEDLINE] Novel markers for the prospective isolation of human MSC. Related Articles Novel markers for the prospective isolation of human MSC. Ann N Y Acad Sci. 2007 Jun;1106:262-71 Authors: B&#xFC;hring HJ, Battula VL, Treml S, Schewe B, Kanz L, Vogel W The isolation of mesenchymal stem cells (MSC) from primary tissue is hampered by the limited selectivity of available markers. So far, CD271 is one of the most specific markers for bone marrow (BM)-derived MSC. In search of additional markers, monoclonal antibodies (mAbs) with specificity for immature cells were screened by flow cytometry for their specific reactivity with the rare CD271(+) population. The recognized CD271(+) populations were fractionated by fluorescence-activated cell sorting and the clonogenic capacity of the sorted cells was analyzed for their ability to give rise to CFU-F. The results showed that only the CD271(bright) but not the CD271(dim) population contained CFU-F. Two-color flow cytometry analysis revealed that only the CD271(bright) population was positive for the established MSC markers CD10, CD13, CD73, and CD105. In addition, a variety of mAbs specific for novel and partially unknown antigens selectively recognized the CD271(bright) population but no other BM cells. The new MSC-specific molecules included the platelet-derived growth factor receptor-beta (CD140b), HER-2/erbB2 (CD340), frizzled-9 (CD349), the recently described W8B2 antigen, as well as cell-surface antigens defined by the antibodies W1C3, W3D5, W4A5, W5C4, W5C5, W7C6, 9A3, 58B1, F9-3C2F1, and HEK-3D6. In conclusion, the described markers are suitable for the prospective isolation of highly purified BM-MSC. These MSC may be used as an improved starting population for transplantation in diseases like osteogenesis imperfecta, cartilage repair, and myocardial infarction. PMID: 17395729 [PubMed - indexed for MEDLINE] Daily treatment with adapalene gel 0.1% maintains initial improvement of acne... Related Articles Daily treatment with adapalene gel 0.1% maintains initial improvement of acne vulgaris previously treated with oral lymecycline. Eur J Dermatol. 2007 Jan-Feb;17(1):45-51 Authors: Alirezai M, George SA, Coutts I, Roseeuw DI, Hachem JP, Kerrouche N, Sidou F, Soto P Topical retinoids are often recommended for preventing acne recurrence, but there are relatively few well-controlled maintenance studies published. The objective of the present study was to assess the maintenance effect of adapalene gel 0.1% relative to gel vehicle in subjects successfully treated in a previous 12-week adapalene-lymecycline 300 mg combination therapy study. This was a multicentre, investigator-blind, randomised, controlled study in 19 European centres. A total of 136 subjects with moderate to moderately-severe acne vulgaris who showed at least moderate improvement from baseline when treated with either adapalene plus lymecycline or lymecycline plus gel vehicle in a previous 12 week study were included. Subjects were randomised to receive adapalene gel 0.1% or vehicle once-daily for 12 weeks. Efficacy and safety criteria included maintenance rate, percent reduction in lesion counts (total, inflammatory, non inflammatory), global severity assessment, cutaneous tolerability, and adverse events. Adapalene provided better results relative to gel vehicle for all efficacy assessments. The maintenance rate for total lesions was 84.7% vs. 63.5% (P = 0.0049) with adapalene and the vehicle, respectively. Adapalene was safe and well tolerated in this study. This study demonstrates a clinical benefit of continued treatment with adapalene gel 0.1% as a maintenance therapy for acne. PMID: 17324827 [PubMed - indexed for MEDLINE] Relationship between sebostatic activity, tolerability and efficacy of three ... Related Articles Relationship between sebostatic activity, tolerability and efficacy of three topical drugs to treat mild to moderate acne. J Eur Acad Dermatol Venereol. 2007 Mar;21(3):320-5 Authors: Stinco G, Bragadin G, Trotter D, Pillon B, Patrone P BACKGROUND: Acne is a multifactorial disorder in which the sebum plays an important pathogenetic role. PURPOSE OF THE STUDY: To evaluate the sebostatic effect of three anti-acneic ingredients (azelaic acid, adapalene and benzoyl peroxide) conveyed in cream and to determine whether there is a correlation with the therapeutic results. MATERIALS AND METHODS: Sixty-five patients with mild or moderate acne localized on the face were divided into three therapy groups at random: 25 applied azelaic acid once a day, 20, benzoyl peroxide and 20, adapalene. All the patients were observed at the time of enrolling and a further four times at fortnightly intervals. At each visit the sebum casual level on the forehead, chin and one cheek was measured using a sebumeter. Furthermore, side-effects and clinical-therapeutic effectiveness were noted. RESULTS: Four patients did not complete the study. Azelaic acid showed an average reduction of 13.9% in sebum production on the forehead, 14.2% on the chin and 15.2% on the cheek. Benzoyl peroxide caused an increase of 10.5% in sebum production on the forehead, 10.3% on the chin and 25.4% on the cheek. Adapalene reduced sebaceous secretion by 0.2% on the forehead and 6.7% on the cheek whereas sebum production increased by 6.2% on the chin. All three drugs showed a clinical improvement in the acneic lesions with moderate adverse effects. CONCLUSION: The three topical drugs bring about good therapeutic results with scarce side-effects that do not, however, seem to be correlated with the sebostatic activity. PMID: 17309452 [PubMed - indexed for MEDLINE] Efficacy and safety of serial glycolic acid peels and a topical regimen in th... Related Articles Efficacy and safety of serial glycolic acid peels and a topical regimen in the treatment of recalcitrant melasma. J Dermatol. 2007 Jan;34(1):25-30 Authors: Erbil H, Sezer E, Ta&#x15F;tan B, Arca E, Kurumlu Z Melasma is a common acquired disorder of facial hyperpigmentation. In this study we investigated the efficacy and safety of a combined treatment regimen including serial glycolic acid peels, topical azelaic acid cream and adapalene gel in the treatment of recalcitrant melasma. Twenty-eight patients with recalcitrant melasma were enrolled in a prospective, randomized, controlled trial lasting 20 weeks. The patients of the group receiving chemical peels underwent serial glycolic acid peels in combination with topical azelaic acid 20% cream (b.i.d.) and adapalene 0.1% gel (q.i.d., applied at night). The control group received only topical treatment including topical azelaic acid and adapalene. The clinical improvement was assessed with the Melasma Area Severity Index (MASI) at baseline and monthly during the 20-week treatment period. The results showed a prominent decrease in MASI scores at the end of the treatment in both groups, although the results were better in the group receiving chemical peels (P=0.048). All patients tolerated the topical agents well with minimal irritation observed in the first few weeks of the therapy. Three patients in the glycolic acid peel group developed a mild-degree postinflammatory hyperpigmentation with total clearance at the end of the treatment period. Therefore, the present study suggests that combined treatment with serial glycolic acid peels, azelaic acid cream and adapalene gel should be considered as an effective and safe therapy in recalcitrant melasma. PMID: 17204097 [PubMed - indexed for MEDLINE] Acneiform eruptions associated with epidermal growth factor receptor-targeted... Related Articles Acneiform eruptions associated with epidermal growth factor receptor-targeted chemotherapy. J Am Acad Dermatol. 2007 Mar;56(3):500-5 Authors: DeWitt CA, Siroy AE, Stone SP A relatively newer class of chemotherapy agents, known as the epidermal growth factor receptor inhibitors (EGF-RIs), is being used to treat advanced stages of solid tumors. Acneiform eruptions are a frequent adverse effect and one which has been associated with increased survival in some studies. We describe 3 patients who presented shortly after initiation of EGF-RI therapy. Characteristics included an absence of comedones, facial and truncal involvement, and a perifollicular lymphoneutrophilic infiltrate detected on biopsy. Lesion counts were reduced with topical adapalene and oral tetracyclines in two patients. Patient 3 had dramatic clearance with low-dose isotretinoin (20 mg daily) until completion of EGF-RI therapy. Acneiform eruptions are a common adverse reaction to EGF-RI therapy and can be treated with traditional acne therapy. This should not be considered a drug hypersensitivity eruption or allergy, and patients should continue therapy. For patients with severe eruptions, oral isotretinoin is a consideration. PMID: 17166623 [PubMed - indexed for MEDLINE] Isolation and characterisation of impurities in adapalene. Related Articles Isolation and characterisation of impurities in adapalene. J Pharm Biomed Anal. 2007 Feb 19;43(3):1161-3 Authors: Brenna E, Frigoli S, Fronza G, Fuganti C, Sala F Three impurities of structure 2-4 were isolated and characterised during the optimisation of a synthetic procedure to adapalene. Impurity 1 was a by-product of the Friedel-Crafts reaction of adamantanol with 4-bromoanisole. Impurities 3 and 4 were due to side reactions of the final Negishi coupling. PMID: 17098391 [PubMed - indexed for MEDLINE] Clinical inquiries. What is the best treatment for mild to moderate acne? Related Articles Clinical inquiries. What is the best treatment for mild to moderate acne? J Fam Pract. 2006 Nov;55(11):994-6 Authors: Rao S, Malik MA, Wilder L, Mott T For mild comedonal acne, monotherapy with topical retinoids is the treatment of choice (strength of recommendation [SOR]: A). For moderate comedonal and mild to moderate papulopustular acne, combination therapy with either benzoyl peroxide or topical retinoids (adapalene [Differin], tazarotene [Tazorac], tretinoin [Retin-A]) plus topical antibiotics (erythromycin or clindamycin) is proven most effective (SOR: A). Six to 8 weeks should be allowed for most treatments to work before altering the regimen (SOR: A). PMID: 17090362 [PubMed - indexed for MEDLINE] Treatment of Cervical Intraepithelial Neoplasia Levels 2 and 3 with Adapalene... Related Articles Treatment of Cervical Intraepithelial Neoplasia Levels 2 and 3 with Adapalene, a Retinoid-Related Molecule. J Low Genit Tract Dis. 2001 Jan;5(1):33-37 Authors: Disilvestro PA, Disilvestro JM, Lernhardt W, Pfahl M, Mannel RS OBJECTIVES: This study examined dose scheduling, safety, and efficacy of adapalene in the treatment of CIN2 and CIN3. METHODS: Patients were instructed on insertion and removal of an adapalene delivery system. Treatment regimens of 4, 8, and 14 days were utilized. Biopsies were performed on day 90 to assess efficacy. Safety was evaluated with toxicity questionnaires and patient interviews. RESULTS: Two patients treated for 4 days had stable disease. Twenty-three patients treated for 8 days demonstrated an overall 61% (14 of 23) response rate. Twenty-four patients treated for 14 days had an overall 38% (9 of 24) response rate. No patient had disease progression. Compared to untreated historical controls, significantly improved efficacy was demonstrated for patients with CIN2. Patients with CIN3 had improved efficacy, though not statistically significant. CONCLUSIONS: The lack of side effects and practicality of home use make adapalene a nontoxic and safe alternative to surgical therapy in patients with CIN2 and CIN3. PMID: 17043560 [PubMed - as supplied by publisher] Schools of pharmacology: retinoid update. Related Articles Schools of pharmacology: retinoid update. J Drugs Dermatol. 2006 Oct;5(9):921-2 Authors: Scheinfeld N The most widely used retinoids include topical tretinoin (Retin-A), adapalene (Differin), topical tazarotene (Tazorac), isotretinoin (Accutane), and acitretin (Soriatane). This article will review new uses and developments in tazarotene (its failure to secure FDA approval in oral form for psoriasis), adapalene (its new 0.3% gel form and use in rosacea), alitretinoin (its use in photoaging), bexarotene (its use for psoriasis and chronic hand dermatitis), isotretinoin (the IPledge program, its use for neuroblastoma and branded formulation pharmacological superiority to generics), and retinoic acid metabolism-blocking agents (RAMBAs) (liarazole use for ichthyosis and psoriasis). PMID: 17039662 [PubMed - indexed for MEDLINE] Retinoid therapy of pigmentary disorders. Related Articles Retinoid therapy of pigmentary disorders. Dermatol Ther. 2006 Sep-Oct;19(5):280-8 Authors: Ortonne JP Topical retinoids such as all-trans-retinoic acid (RA), 13-cis-retinoic acid (isotretinoin), retinol, retinaldehyde, tazarotene, and adapalene have been shown to improve dyspigmentation of photodamaged skin including mottling and actinic lentigines. RA monotherapy has also been demonstrated to improve melasma and postinflammatory hypermelanosis. Furthermore, RA in combination with hydroquinone or 4-hydroxyanisole, or azelaic acid increases the potency of depigmenting agents for the treatment of melasma, actinic lentigines, and postinflammatory hypermelanosis. The basic mechanisms underlying these effects are not completely identified. Topical retinoids stimulate the cell turn-over of epidermal keratinocytes and promote a decrease in melanosome transfer and a rapid loss of melanins via epidermopoiesis. Topical retinoids are also involved in the control of cell differentiation. Retinoid-induced changes in the stratum corneum and the permeability barrier may also facilitate the penetration of depigmenting agents in the epidermis and increase their bioavailability, leading to increased depigmentation. In addition, several in vitro studies demonstrate that cis and trans-retinoic acid inhibit UV-B stimulated melanogenesis in term of tyrosinase activity and melanin synthesis. It is likely that topical retinoids modulate epidermal melanin count via a direct action on melanocytes and epidermal keratinocytes. PMID: 17014483 [PubMed - indexed for MEDLINE] Treatment considerations for inflammatory acne: clinical evidence for adapale... Related Articles Treatment considerations for inflammatory acne: clinical evidence for adapalene 0.1% in combination therapies. J Drugs Dermatol. 2006 Sep;5(8):785-94 Authors: Thiboutot DM, Gollnick HP Acne vulgaris is an exceptionally common, chronic, and recurring disease. It involves multiple etiological factors including follicular hyperkeratinization, increased sebum production, Propionibacterium acnes proliferation, and inflammation. Presently, oral isotretinoin is the only single agent that is effective against all 4 major pathophysiologic features. However, this drug is also responsible for several serious side effects, including teratogenicity. Therefore, it should be used in only the most severe cases and alternative treatment approaches for inflammatory acne, such as initial combination therapy, should be considered first. Combination therapy in inflammatory acne simultaneously targets multiple pathogenic factors. Current guidelines recommend early initiation of combination therapy with a topical retinoid and antimicrobials for mild to moderate inflammatory acne and topical retinoids with oral antibiotics (with or without the use of benzoyl peroxide) for moderate to severe cases of acne, followed by maintenance therapy with topical retinoids. This review evaluates the rationale and clinical evidence for the use of adapalene in combination therapy for inflammatory acne. PMID: 16989194 [PubMed - indexed for MEDLINE] Defining criteria used to evaluate response to treatment of acne vulgaris. Related Articles Defining criteria used to evaluate response to treatment of acne vulgaris. Cutis. 2006 Aug;78(2):117-21 Authors: Del Rosso JQ Results from controlled studies form the basis of overall perceptions regarding the efficacy and safety of specific treatments. In acne vulgaris, determining statistical significance related to mean percentage reduction in inflammatory and noninflammatory lesion counts, investigator global assessment, and patient (subject) global assessment have formed the basis of most studies. Results may be impacted by several mitigating factors related to inclusion and exclusion criteria and variations in study "power." Recently, standards for evaluation of response to acne treatment have been reconsidered, with new methodologies suggested throughout the approval process. For example, the standard of "complete clearance" has been introduced. How the new methodologies compare with previous standards, and how new criteria will impact the reporting and interpretation of trial results are reviewed in this article. Specific study outcomes, including those reported in more recent trials with topical adapalene, are utilized as illustrative examples. PMID: 16983900 [PubMed - indexed for MEDLINE] Acne vulgaris. Related Articles Acne vulgaris. Clin Evid. 2006 Jun;(15):2183-201 Authors: Purdy S PMID: 16973084 [PubMed - indexed for MEDLINE] Cumulative irritancy comparison of topical retinoid and antimicrobial combina... Related Articles Cumulative irritancy comparison of topical retinoid and antimicrobial combination therapies. Skinmed. 2006 Sep-Oct;5(5):219-23 Authors: Dosik JS, Gilbert RD, Arsonnaud S BACKGROUND: The use of multiple topical drugs for the treatment of acne may cause elevated irritation. Therefore, the selection of a combination regimen should include a careful consideration of the irritation potential of the individual acne medications. OBJECTIVE AND METHODS: To compare the cumulative irritation potential of adapalene gel 0.1%, tazarotene cream 0.05%, and tretinoin microsphere 0.04% when applied in combination with two benzoyl peroxide/clindamycin topical gels in 35 healthy subjects in a 3-week, randomized, controlled study. RESULTS: The mean cumulative irritancy index of adapalene combinations was significantly lower relative to tretinoin and tazarotene regimens (all P<.01). Test areas exposed to tretinoin or tazarotene were also more likely to be discontinued for severe irritation than those exposed to adapalene. There were no serious adverse events. No significant difference in the irritancy potentials of tazarotene and tretinoin combination regimens was observed. CONCLUSIONS: Adapalene gel 0.1% has tolerability superior to both tazarotene cream 0.05% and tretinoin microsphere 0.04% when used in topical combination therapy. In view of the lower irritation potential observed in this study, along with its demonstrated efficacy, adapalene gel 0.1% in combination with antimicrobial agents may be used as part of an aggressive treatment regimen for the management of acne. PMID: 16957432 [PubMed - indexed for MEDLINE] Subject preferences for acne treatments containing adapalene gel 0.1%: result... Related Articles Subject preferences for acne treatments containing adapalene gel 0.1%: results of the MORE trial. Cutis. 2006 Jul;78(1 Suppl):26-33 Authors: Cook-Bolden F Acne vulgaris can affect adolescents at a time of profound physical, social, and psychological change. The negative impact of acne on self-image and self-confidence can be severe, leading to potential psychiatric problems and limiting social interactions, even in adults. Adherence is necessary for successful treatment of acne, and patient satisfaction is crucial for adherence. The Measuring Acne Outcomes in a Real-World Experience (MORE) trial enrolled 1979 subjects who used combination acne treatments, all containing adapalene gel 0.1%. Among other measures, subjects were surveyed regarding their satisfaction with treatment. Adherence to treatment protocol was high throughout the study (94.5% and 88.0% at weeks 6 and 12, respectively, determined by self-report, and 93.7% and 80.3%, respectively, determined by filled prescriptions). Of the subjects who completed preference surveys, more than 70% rated adapalene gel 0.1% as much superior or superior to other acne treatments; more than 85% of subjects were very satisfied or satisfied with adapalene gel 0.1% to treat their acne; and more than 85% of subjects reported feeling more confident or positive after using this treatment. About 75% of subjects planned to continue using adapalene gel 0.1% and/or use it in the future if they needed acne treatment, and close to 75% of subjects indicated that they would recommend this treatment to a friend. The high level of patient satisfaction with adapalene gel 0.1% as an acne treatment is likely to translate into a high level of adherence to treatment, including maintenance treatment, and a major improvement in quality of life (QOL) for patients with acne. PMID: 16910028 [PubMed - indexed for MEDLINE] Safety and tolerability in the MORE trial. Related Articles Safety and tolerability in the MORE trial. Cutis. 2006 Jul;78(1 Suppl):19-25 Authors: Wolf JE Adverse events and a high potential for cutaneous irritation may have a negative effect on patient adherence to acne treatments, the primary factor contributing to optimal outcomes. In addition to effectiveness and subject satisfaction, the Measuring Acne Outcomes in a Real-World Experience (MORE) trial evaluated adverse events and cutaneous tolerability of adapalene gel 0.1% in 1396 subjects who received initial combination therapy with adapalene gel 0.1% and 468 subjects who added adapalene gel 0.1% to their existing regimen (safety population). Adverse events were uncommon (reported by 5.8% of subjects) and generally mild, the most frequent being skin and subcutaneous tissue disorders (2.7%). Overall, investigators rated cutaneous tolerability as high. Adherence to therapy also was high with both the initial combination and add-on therapies. The MORE trial confirms that adapalene gel 0.1% is safe and well tolerated and therefore likely to enhance adherence to treatment and the likelihood of optimal treatment outcomes for patients with moderate to moderately severe acne. PMID: 16910027 [PubMed - indexed for MEDLINE] The MORE trial: effectiveness of adapalene gel 0.1% in real-world dermatology... Related Articles The MORE trial: effectiveness of adapalene gel 0.1% in real-world dermatology practices. Cutis. 2006 Jul;78(1 Suppl):12-8 Authors: Gold LS Effective treatment of acne often involves combination therapy. Topical retinoids are effective when used in combination with topical and/or oral antibiotics, and recent guidelines from the Global Alliance to Improve Outcomes in Acne recommend retinoids as part of initial and maintenance therapies. The Measuring Acne Outcomes in a Real-World Experience (MORE) trial evaluated the effectiveness, tolerability, and acceptability of adapalene gel 0.1% in combination with other acne treatments for subjects with moderate to moderately severe acne, either as an initial combination regimen for subjects not treated at baseline or as add-on therapy for patients already treated for acne. Of 1979 subjects aged 12 years or older who were enrolled, 1662 completed the 12-week assessment using adapalene gel 0.1% once daily for 12 weeks according to protocol. Adherence to therapy was high for both the initial combination and add-on therapies with adapalene gel 0.1%. Significant reductions in acne lesions were seen as early as week 6 and were even more pronounced by week 12 (P < .001 vs baseline for all lesion types at both weeks 6 and 12). A majority of investigators rated adapalene gel 0.1% superior to other acne treatments they had prescribed, and the success rate also was high based on the Investigator Global Assessment. The MORE trial confirms that adapalene gel 0.1% is effective in clearing both inflammatory and noninflammatory acne lesions in patients with moderate to moderately severe acne. PMID: 16910026 [PubMed - indexed for MEDLINE] The results of the MORE trial: overview. Related Articles The results of the MORE trial: overview. Cutis. 2006 Jul;78(1 Suppl):5-11 Authors: Campbell JL, Weiss JS Successful treatment of acne requires knowledge of the performance capabilities of available treatments and patient expectations. The Measuring Acne Outcomes in a Real-World Experience (MORE) trial was a prospective, open-label, multicenter, observational, phase 4 study of the effectiveness and safety of adapalene gel 0.1% when used with other acne treatments, either as part of an initial combination regimen or as add-on therapy. The MORE trial also surveyed subjects regarding their satisfaction with treatment and their rating of adapalene gel 0.1% versus acne treatments they had previously used. Enrollment consisted of 1979 subjects aged 12 years or older; 1662 subjects completed the week 12 assessment, using adapalene gel 0.1% once daily for 12 weeks according to protocol. Significant reductions in the number of acne lesions were seen as early as week 6 and were even more pronounced by week 12 (P <. 001 vs baseline for all lesion types at both weeks 6 and 12). Adverse events were uncommon (5.8% of subjects) and were generally mild, with the most common being skin or subcutaneous tissue disorders. Adherence to therapy was high for both the initial combination and add-on therapies. Subjects expressed a high degree of satisfaction with and preference for adapalene gel 0.1% over previous treatments. The MORE trial corroborates the general consensus regarding the efficacy of combination therapy including a topical retinoid and demonstrates that adapalene gel 0.1% is effective, well tolerated, and likely to enhance adherence to treatment. PMID: 16910025 [PubMed - indexed for MEDLINE] The MORE trial: relevance to everyday dermatology practices. Related Articles The MORE trial: relevance to everyday dermatology practices. Cutis. 2006 Jul;78(1 Suppl):3-4 Authors: Weiss JS, Campbell JL PMID: 16910024 [PubMed - indexed for MEDLINE] Adapalene gel, 0.1%, as maintenance therapy for acne vulgaris: a randomized, ... Related Articles Adapalene gel, 0.1%, as maintenance therapy for acne vulgaris: a randomized, controlled, investigator-blind follow-up of a recent combination study. Arch Dermatol. 2006 May;142(5):597-602 Authors: Thiboutot DM, Shalita AR, Yamauchi PS, Dawson C, Kerrouche N, Arsonnaud S, Kang S OBJECTIVE: To assess the maintenance effect of adapalene gel, 0.1%, relative to gel vehicle in subjects successfully treated in a previous 12-week study of adapalene-doxycycline, 100 mg, combination therapy. DESIGN: Multicenter, investigator-blind, randomized, controlled study. SETTING: Thirty-four US centers. SUBJECTS: A total of 253 subjects with severe acne vulgaris who showed at least moderate improvement from baseline (50% improvement from baseline) when treated with either adapalene plus doxycycline or doxycycline plus gel vehicle in a previous 12-week study. INTERVENTIONS: Subjects were randomized to receive adapalene gel, 0.1%, or gel vehicle once daily for 16 weeks. MAIN OUTCOME MEASURES: Efficacy and safety criteria included maintenance rate (subjects maintaining at least 50% improvement in lesion counts from previous therapy), lesion counts (total, inflammatory, and noninflammatory), global severity assessment, cutaneous tolerability, and adverse events. RESULTS: Adapalene maintenance therapy resulted in significantly larger maintenance rates (75% vs 54%; P<.001) and significantly lower lesion counts (total [P = .005], inflammatory [P = .01], and noninflammatory [P = .02]) compared with gel vehicle. Adapalene was safe and well tolerated in this study.Conclusion This study demonstrates a clinical benefit of continued treatment with adapalene gel, 0.1%, as a maintenance therapy for acne. PMID: 16702497 [PubMed - indexed for MEDLINE] Treatment of solar lentigines. Related Articles Treatment of solar lentigines. J Am Acad Dermatol. 2006 May;54(5 Suppl 2):S262-71 Authors: Ortonne JP, Pandya AG, Lui H, Hexsel D Therapy for solar lentigines is diverse but can be divided into two broad categories: physical therapy and topical therapy. Physical therapies are frequently used with excellent clinical success rates, but this has to be balanced against associated side effects and recurrence rates with certain therapies. A range of topical therapies have been used and, more recently, fixed combinations of topical agents have been investigated. The Pigmentary Disorders Academy undertook to evaluate the clinical efficacy of the different treatments of solar lentigines in order to generate a consensus statement on their management. Clinical papers published during the past 20 years were identified through MEDLINE searches and methodology and outcome were assessed according to guidelines adapted from the US Preventive Services Task Force (USPSTF) on health care. The consensus of the group was that first-line therapy for solar lentigines was ablative therapy with cryotherapy. Although no large-scale studies have been completed, there is also good evidence to suggest that lasers are an effective treatment. An alternative to ablative therapy is topical therapy and there is good evidence to support the use of a fixed double combination, as well as retinoids, such as adapalene and tretinoin. Topical therapy can also be considered as maintenance therapy after the primary therapy has been applied. Because of the diversity of scoring systems used in the assessment of treatment outcome, the group recommends the development of treatment guidelines. PMID: 16631967 [PubMed - indexed for MEDLINE] Adapalene gel 0.3% for the treatment of acne vulgaris: a multicenter, randomi... Related Articles Adapalene gel 0.3% for the treatment of acne vulgaris: a multicenter, randomized, double-blind, controlled, phase III trial. J Am Acad Dermatol. 2006 Feb;54(2):242-50 Authors: Thiboutot D, Pariser DM, Egan N, Flores J, Herndon JH, Kanof NB, Kempers SE, Maddin S, Poulin YP, Wilson DC, Hwa J, Liu Y, Graeber M, BACKGROUND: A new 0.3% gel formulation of adapalene has been developed. OBJECTIVE: We sought to provide evidence of the superiority of adapalene gel 0.3% over adapalene gel 0.1% and gel vehicle in the treatment of acne. METHODS: A total of 653 patients were randomized to receive adapalene gel 0.3%, adapalene gel 0.1%, or vehicle once daily for 12 weeks (2:2:1 randomization). Analysis for efficacy was conducted on correlated repeated measurements at weeks 8 and 12 using Generalized Estimating Equation methodology. RESULTS: Adapalene gel 0.3% was significantly superior to adapalene gel 0.1% and vehicle in success rate, total lesion count, and inflammatory lesion count. A consistent, dose-dependent effect was demonstrated for all efficacy measures. Signs and symptoms were mostly mild to moderate and transient in nature. LIMITATIONS: Adjunctive topical or oral agents and their impact on acne were not studied in this trial. CONCLUSIONS: Adapalene gel 0.3% was effective and well tolerated in the treatment of acne. PMID: 16443054 [PubMed - indexed for MEDLINE] Pseudoacne of the nasal crease in a patient with congenital deafness and pigm... Related Articles Pseudoacne of the nasal crease in a patient with congenital deafness and pigmentary mosaicism. Pediatr Dermatol. 2005 Nov-Dec;22(6):575-6 Authors: Mart&#xED;n JM, Jordá E, Alonso V, Villalón G PMID: 16354272 [PubMed - indexed for MEDLINE] Comedolytic effect of a novel RARgamma-specific retinoid, ER36009: comparison... Related Articles Comedolytic effect of a novel RARgamma-specific retinoid, ER36009: comparison with retinoic acid in the rhino mouse model. Eur J Dermatol. 2005 Nov-Dec;15(6):459-64 Authors: Sakuta T, Kanayama T In addition to natural retinoids, new synthetic retinoids, such as adapalene and tazarotene, are currently available for the treatment of acne. In this study, we evaluated the comedolytic effect of a novel retinoic acid receptor (RAR)-gamma specific retinoid, ER36009, in the rhino mouse. The animals were treated for five days a week with ER36009 (0.00001, 0.000025, 0.00010, 0.00025%), all-trans-retinoic acid (RA) (0.001, 0.005, 0.010, 0.050%), two commercial formulations (Differine((R)) 0.1% adapalene gel, and Tazorac 0.1% tazarotene gel) and acetone as a control, for two weeks. After the treatments, utricle diameter and apoptosis of the follicular epidermis were examined. ER36009 was 96 times more potent than RA in the utricle diameter reduction assay. It also eliminated apoptosis of the follicular epidermis and restored normal apoptosis at the granular layer. These data indicate that ER36009 is a potent comedolytic agent compared with other currently available retinoids. PMID: 16280299 [PubMed - indexed for MEDLINE] The efficacy and safety of adapalene gel 0.3% in the treatment of acne vulgar... Related Articles The efficacy and safety of adapalene gel 0.3% in the treatment of acne vulgaris: A randomized, multicenter, investigator-blinded, controlled comparison study versus adapalene gel 0.1% and vehicle. Cutis. 2005 Aug;76(2):145-51 Authors: Pariser DM, Thiboutot DM, Clark SD, Jones TM, Liu Y, Graeber M, A randomized, multicenter, investigator-blinded, active- and vehicle-controlled study was conducted to evaluate the efficacy and safety of adapalene gel 0.3% versus adapalene gel 0.1% and the corresponding gel vehicle. Subjects were assigned randomly to receive either adapalene gel 0.3%, adapalene gel 0.1%, or vehicle once daily for 12 weeks. A total of 214 subjects with moderate to moderately severe acne vulgaris were enrolled, and 85% of subjects completed the study. Adapalene gel 0.3% was significantly superior to adapalene gel 0.1% in total and noninflammatory lesion counts and in global severity score (P < .05 for all). A concentration-dependent increase in clinical benefit for all efficacy assessments was observed. As expected, there were also statistically significant differences in all efficacy parameters in the adapalene gel 0.3% group relative to the vehicle group (P < .001 for all). Treatment-related adverse events were mostly mild-to-moderate and similar between active groups. The results of this study show that adapalene gel 0.3% was superior to adapalene gel 0.1% and vehicle in the treatment of moderate to moderately severe acne while retaining a similar safety and tolerability profile to adapalene 0.1% gel. PMID: 16209161 [PubMed - indexed for MEDLINE] Acne vulgaris. Acne vulgaris. Clin Evid. 2005 Jun;(13):2038-59 Authors: Purdy S PMID: 16135322 [PubMed - indexed for MEDLINE] [Rosacea. Clinical features, pathogenesis and therapy] Related Articles [Rosacea. Clinical features, pathogenesis and therapy] Hautarzt. 2005 Sep;56(9):871-85; quiz 886-7 Authors: Lehmann P Rosacea is a common facial dermatosis, which may have detrimental effects on the patient's psychological and social interactions. It is a disease of the middle aged, skin types I and II are more often affected than darker skin types. Clinically, pre-rosacea, and rosacea grade I-III may be distinguished. Pre-rosacea is characterized by flushing and blushing, grade I to III by erythemato-teleangiectasies, papulopustules, and inflammatory nodules. Especially severe subtypes include rosacea conglobata and rosacea fulminans. Hyperglandular subtypes lead to different forms of phyma, of which Rhinophyma is the most frequent. Pathogenetically destruction of the dermal vessels and connective tissue seems to be decisive for the development of a chronic inflammation, which leads to the phenotype of the various forms of rosacea. Mild forms can be treated exclusively by topical medication. Antibiotics (erythromycin, clindamycin, tetracyclin), metronidazol, azelaic acid, and the retinoid adapalene have been shown to be effective in well controlled randomized studies. The best evaluated topical medication is metronidazol. In severe forms systemic therapy must be applied. Systemic antibiotics are effective and especially isotretinoin has shown a very good response even in low dose regimens. Rhinophyma must be treated surgically. PMID: 16133636 [PubMed - indexed for MEDLINE] Anti-inflammatory effects of tretinoin (all-trans-retinoic acid) 0.1% and ada... Related Articles Anti-inflammatory effects of tretinoin (all-trans-retinoic acid) 0.1% and adapalene 0.1% in rats. Clin Exp Dermatol. 2005 Sep;30(5):570-2 Authors: Akdeniz N, Calka O, Ozbek H, Metin A In this study, the anti-inflammatory effects of tretinoin (all-trans-retinoic acid) 0.1% cream and adapalene 0.1% gel were compared in rats to determine whether there was a difference between these agents. Thirty-six rats of either sex were divided into six groups (two control groups, and an etodolac, indomethacin, tretinoin and adapalene group) of six animals each. Each group was given different drugs or chemicals. The inhibitory activities of the drugs were determined on carrageenan-induced rat-paw oedema. The inhibition rate (53.48%) in the tretinoin group was found to be higher than adapalene and controls (P < 0.05). Adapalene was found to have an inhibition rate of 10.28%, and when compared with the other groups, was found to have no statistically significant anti-inflammatory activity. We conclude that tretinoin has a higher anti-inflammatory activity than adapalene and thus should be preferred for the treatment of inflammatory lesions. PMID: 16045694 [PubMed - indexed for MEDLINE] Cumulative irritation potential of adapalene 0.1% cream and gel compared with... Related Articles Cumulative irritation potential of adapalene 0.1% cream and gel compared with tazarotene cream 0.05% and 0.1%. Cutis. 2005 May;75(5):289-93 Authors: Dosik JS, Homer K, Arsonnaud S Despite the many beneficial effects of dermatologic applications, most of the current treatments for acne cause local irritation. The objective of this study was to compare the ability of the epidermis to tolerate adapalene 0.1% cream and gel and tazarotene cream in concentrations of 0.05% and 0.1%. A total of 30 subjects were enrolled in the study. The test products were applied under occlusive dressings at randomized sites on the upper back for approximately 24 hours, 4 times a week, and for 72 hours, once a week, for a period of 3 weeks. Skin reactions (erythema score plus other local reactions) at the product application sites were assessed 15 to 30 minutes after dressing removal. Twenty-six subjects completed the study. A total of 16 subjects discontinued use of 1 or more of the test products because of irritation scores reaching severe or greater; all but one of these discontinuations were at sites treated with the tazarotene products. The mean 21-day cumulative irritancy indices for adapalene 0.1% cream and gel were significantly lower (P=.05) than those for tazarotene cream 0.05% and 0.1% and not notably higher than that of the negative control product. PMID: 15984630 [PubMed - indexed for MEDLINE] Topical retinoids during pregnancy (continued). Related Articles Topical retinoids during pregnancy (continued). Prescrire Int. 2005 Jun;14(77):100-1 Authors: (1) In 1998 several cases of malformations similar to those induced by oral retinoids were reported in children exposed in utero to topical retinoids (adapalene and tretinoin). The results of two somewhat flawed epidemiological studies were reassuring. (2) New cases of birth defects were subsequently reported in children exposed in utero to topical tretinoin. (3) Epidemiological data are still scant and unconvincing: they neither confirm this risk nor rule it out completely. (4) It is best to avoid using topical retinoids altogether in early pregnancy. Women of child-bearing age must be fully informed of the risks and the importance of effective contraception. This also applies to patients with moderate forms of psoriasis, for which topical tazaroten is indicated. PMID: 15981398 [PubMed - indexed for MEDLINE] Cumulative irritation potential of adapalene 0.1% cream and gel compared with... Related Articles Cumulative irritation potential of adapalene 0.1% cream and gel compared with tretinoin microsphere 0.04% and 0.1%. Cutis. 2005 Apr;75(4):238-43 Authors: Dosik JS, Homer K, Arsonnaud S Despite the many beneficial effects of dermatologic applications, most of the current treatments for acne cause local irritation. The objective of this study was to compare the ability of the epidermis to tolerate adapalene 0.1% cream and gel and tretinoin microsphere in concentrations of 0.04% and 0.1%. A total of 31 subjects were enrolled in the study. The test products were applied under occlusive dressings on the upper back for approximately 24 hours, 4 times a week, and for 72 hours, once a week, for a period of 3 weeks. Skin reactions (erythema score plus other local reactions) at the product application sites were assessed 5 to 30 minutes after dressing removal. Twenty-six subjects completed the study. A total of 10 subjects discontinued use of 1 or more of the test products because of irritation scores reaching severe or greater, all of these discontinuations were at sites treated with the tretinoin products. The mean 21-day cumulative irritancy indices for adapalene 0. 1% cream and gel were significantly lower (P<.01) than those for tretirnoin microsphere 0.04% and 0. 1% and not higher than that of the negative control product. PMID: 15916222 [PubMed - indexed for MEDLINE] Mechanism-based treatment of acne vulgaris: the value of combination therapy. Related Articles Mechanism-based treatment of acne vulgaris: the value of combination therapy. J Drugs Dermatol. 2005 May-Jun;4(3):281-8 Authors: Webster G Acne vulgaris has multiple pathogenic mechanisms that act in concert to produce disease. Effective therapy addresses more than one pathogenic factor to speed resolution of disease. Typically, retinoids are used to inhibit comedo formation and an antibacterial is used to suppress Propionibacterium acnes (P. acnes). Using combinations of agents can enhance efficacy, but increase side effects. Therefore, the tolerability of a topical retinoid is important. Strategies to enhance retinoid tolerability include the use of new retinoids such as adapalene, new delivery systems such as the tretinoin microsphere delivery system, or alternative dosing schedules such as short contact or every other day (QOD). PMID: 15898282 [PubMed - indexed for MEDLINE] Combination therapy with adapalene gel 0.1% and doxycycline for severe acne v... Related Articles Combination therapy with adapalene gel 0.1% and doxycycline for severe acne vulgaris: a multicenter, investigator-blind, randomized, controlled study. Skinmed. 2005 May-Jun;4(3):138-46 Authors: Thiboutot DM, Shalita AR, Yamauchi PS, Dawson C, Arsonnaud S, Kang S, BACKGROUND: Combination therapy with a topical retinoid and an antibiotic is recognized as a rational and effective approach for the treatment of acne vulgaris. Adapalene, a naphthoic acid derivative with anti-inflammatory and receptor-selective retinoid properties, is safe and well tolerated. While the combination of adapalene with oral or topical antibiotics has been shown to deliver a superior and faster response than an antibiotic alone, the clinical benefits of a combination of adapalene and doxycycline, the most frequently prescribed oral antibiotic for acne in the United States, have yet to be evaluated. OBJECTIVE AND METHODS: In a 12-week study, the efficacy and safety of the combination of adapalene gel 0.1% with doxycycline was compared with doxycycline alone for the treatment of severe acne. Subjects were randomized to receive doxycycline once daily in the morning and either adapalene or vehicle once daily in the evening. RESULTS: At Week 12, the combination adapalene-doxycycline was significantly superior to doxycycline alone for change from baseline in total (p<0.001), inflammatory (p=0.02), and noninflammatory (p<0.001) lesions. Significant differences in total lesions were observed as early as Week 4 (p=0.04). Both treatments were well tolerated, and no serious adverse events were reported. CONCLUSIONS: The study demonstrates that the combination of adapalene and an oral antibiotic provides a superior and faster benefit than antibiotic therapy alone and should be considered at the initiation of treatment. PMID: 15891249 [PubMed - indexed for MEDLINE]

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