Randomised,controlled trial of the efficacy and safety of adapalene gel 0.1% and tretinoin cream 0.05% in patients with acne vulgaris

BACKGROUND: Previous clinical trials have shown that adapalene gel produces less irritation than tretinoin gels and tretinoin 0.025% cream. Short term results have shown that adapalene is less irritating than tretinoin gels and creams. This study is the first to compare the 0.1% formulation of adapalene gel with the 0.05% strength of tretinoin cream in a formal clinical trial. OBJECTIVE: To investigate the efficacy and tolerability of adapalene gel 0.1% compared with tretinoin cream 0.05% in patients with mild-to-moderate acne vulgaris. METHODS: Ten-week, multicentre, randomised, investigator-masked, active-controlled, parallel group study in 409 patients with acne vulgaris. RESULTS: Adapalene gel 0.1% demonstrated equivalent efficacy in reduction of acne lesion counts and global improvement of acne severity over 10 weeks' treatment and was significantly better tolerated than tretinoin cream 0.05% in terms of erythema, dryness, desquamation and stinging/burning. CONCLUSION: Adapalene gel 0.1% showed equivalent efficacy and was significantly better tolerated than tretinoin cream 0.05% in patients with mild-to-moderate acne vulgaris.     

Adapalene gel 0.1% is effective and safe for Japanese patients with acne vulgaris: a randomized, multicenter, investigator-blinded, controlled study

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.     

Adapalene gel, 0.1%, as maintenance therapy for acne vulgaris: a randomized, controlled, investigator-blind follow-up of a recent combination study

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.     

Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel

Adapalene 0.1%/benzoyl peroxide 2.5% gel (Epiduo?, Tactuo?) is the only fixed-dose combination product available that combines a topical retinoid with benzoyl peroxide; it targets three of the four main pathophysiologic factors in acne. This article reviews the therapeutic efficacy and tolerability of topical adapalene 0.1%/benzoyl peroxide 2.5% gel in the treatment of patients aged ≥ 12 years with acne vulgaris, as well as summarizing its pharmacologic properties. In three 12-week trials in patients aged ≥12 years with moderate acne, success rates were significantly higher with adapalene 0.1%/benzoyl peroxide 2.5% gel than with adapalene 0.1% gel or benzoyl peroxide 2.5% gel alone, and combination therapy had an earlier onset of action. In addition, significantly greater reductions in total, inflammatory, and noninflammatory lesion counts were seen in patients receiving adapalene 0.1%/benzoyl peroxide 2.5% gel than in those receiving adapalene 0.1% gel or benzoyl peroxide 2.5% gel alone. Adapalene 0.1%/benzoyl peroxide 2.5% gel did not significantly differ from clindamycin 1%/benzoyl peroxide 5% gel in terms of the reduction in the inflammatory, noninflammatory, or total lesion counts in patients with mild to moderate acne, according to the results of a 12-week trial. Twelve-week studies showed that topical adapalene 0.1%/benzoyl peroxide 2.5% gel in combination with oral lymecycline was more effective than oral lymecycline alone in patients with moderate to severe acne, and topical adapalene 0.1%/benzoyl peroxide 2.5% gel in combination with oral doxycycline hyclate was more effective than oral doxycycline hyclate alone in patients with severe acne. In patients with severe acne who responded to 12 weeks’ therapy with topical adapalene 0.1%/benzoyl peroxide 2.5% gel plus oral doxycycline hyclate or oral doxycycline hyclate alone, an additional 6 months’ therapy with adapalene 0.1%/benzoyl peroxide 2.5% gel was more effective than vehicle gel at maintaining response, with further improvement seen in adapalene 0.1%/benzoyl peroxide 2.5% gel recipients. A noncomparative study also demonstrated the efficacy of 12 months’ therapy with adapalene 0.1%/benzoyl peroxide 2.5% gel in patients with acne vulgaris. Topical adapalene 0.1%/benzoyl peroxide 2.5% gel was generally well tolerated in patients with acne. In 12-week trials, the most commonly occurring treatment-related adverse events included erythema, scaling, dryness, and stinging/burning; these dermatologic treatment-related adverse events were usually of mild to moderate severity, occurred early in the course of treatment, and resolved without residual effects. Topical adapalene 0.1%/benzoyl peroxide 2.5% gel was generally well tolerated in the longer term, with dry skin being the most commonly occurring treatment-related adverse event over 12 months of treatment. In conclusion, adapalene 0.1%/benzoyl peroxide 2.5% gel is a valuable agent for the first-line treatment of acne vulgaris.     

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

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.     

Adapalene gel 0.1% in the treatment of infantile acne: an open clinical study

Abstract:  Infantile acne is an uncommon condition in pediatric age. We determined the efficacy and safety of adapalene gel 0.1% in the treatment of infantile acne. Twelve patients were enrolled for adapalene gel 0.1% application once daily over a 16-week treatment period. Efficacy evaluation included counting the inflammatory and noninflammatory lesions by the physician and global evaluation of the improvement. After 16 weeks all patients were followed up for a 1-year period. The time of clearance of the infantile acne lesions was 3 months in four (33%) patients and 4 months in eight (67%) patients (median 3.4 months). Adapalene gel produced reductions in noninflammatory and inflammatory lesions counts. Limited side effects were observed and none of them required stopping the therapy. No patient was left with scarring. Three patients were showed mild lesions in the 1-year follow-up period. Adapalene gel 0.1% was found to be a highly effective and safe drug in the treatment of mild-to-moderate infantile acne.     

Daily treatment with adapalene gel 0.1% maintains initial improvement of acne vulgaris previously treated with oral lymecycline

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.     

0.1%阿达帕林凝胶预防和减轻寻常痤疮复发的多中心随机对照临床试验

目的评价0.1%阿达帕林凝胶维持治疗对于预防和减轻寻常痤疮复发的作用.方法采用多中心、区组随机、开放、对照的方法,共入选患者246例,均为经过阿达帕林和克林霉素(特丽仙)联合治疗或特丽仙单独治疗获得有效(改善≥25%)的寻常痤疮患者,随机分为两组,一组外用0.1%阿达帕林凝胶,另一组不用药,均观察12周.结果239例患者完成治疗和观察,阿达帕林组121例,对照组118例.治疗4周后阿达帕林组炎性皮损数的减少显著优于对照组(P＜0.05),并维持至12周;治疗8周后阿达帕林组皮损总数和非炎性皮损数的减少也显著优于对照组(P＜0.01),并维持至12周.治疗结束后,阿达帕林组总体改善率为66.9%,对照组为4.2%(P＜0.01);阿达帕林组总复发率为4.1%,对照组为83.9%;两组间差异有显著性(P＜0.01).阿达帕林组有个别病例有轻度局部刺激反应,两组间不良反应差异无显著性(P＜0.05).结论阿达帕林凝胶可有效地治疗寻常痤疮,并维持治疗效果,且不增加局部刺激反应,对于减少病情复发具有显著效果.     

Tazarotene gel is safe and effective in the treatment of acne vulgaris: a multicenter, double-blind, vehicle-controlled study.

Retinoids reverse the abnormal pattern of keratinization seen in acne vulgaris. Tazarotene is the first of a novel family of topical receptor-selective acetylenic retinoids. This study evaluates the safety and efficacy of topical tazarotene 0.1% and 0.05% gels, in comparison to vehicle gel, applied once daily for 12 weeks, in the treatment of mild-to-moderate facial acne vulgaris. A total of 446 patients with facial acne vulgaris were enrolled, and 375 patients, ranging in age from 14 to 44 years, were evaluable in this multicenter, double-blind, randomized study. In comparison to vehicle gel, treatment with tazarotene 0.1% gel resulted in significantly greater reductions in noninflammatory and total lesion counts at all follow-up visits, and inflammatory lesion counts at Week 12. Tazarotene 0.05% gel resulted in significantly greater reductions in noninflammatory and total lesion counts than vehicle gel at Weeks 8 and 12. At Week 12, treatment success rates were 68% and 51% for tazarotene 0.1% and 0.05%, respectively (40% for vehicle gel). Tazarotene gel was an effective, safe, and generally well-tolerated therapy for the treatment of acne vulgaris.     

Benzoyl peroxide, adapalene, and their combination in the treatment of acne vulgaris

Benzoyl peroxide and adapalene are among the most effective topical agents used in the treatment of acne. We planned an open-labeled, prospective study to compare the effects and side effects of these two drugs alone and in combination in the treatment of acne vulgaris. One hundred and five consecutive patients (30 men and 75 women) with acne vulgaris were included in this study. The patients were randomly divided into three groups with 35 patients in each. The groups were randomly assigned to 0.1% adapalene gel, 5% benzoyl peroxide lotion, or combination of 0.1% adapalene gel +5% benzoyl peroxide treatment. Acne lesions were classified as noninflammatory (open and closed comedones) and inflammatory (papule, pustule, nodule, cyst), and the lesions on the face were counted before the therapy, during the control visits, and after the treatment. Erythema, dryness, burning, and other side effects were recorded during the treatment. The mean age of the patients was 18.44 +/- 3.75 years. Eight patients were excluded because of noncompliance with the treatment regimen or the follow-up schedule, and four patients were excluded due to allergic contact dermatitis. The study revealed that all three therapy protocols were effective in treating noninflammatory and inflammatory lesions in acne vulgaris (p<0.05) and that there was no significant difference between the groups in efficacy or side effects (p>0.05). Adapalene and benzoyl peroxide are effective and well tolerated agents for acne vulgaris; combination therapy has no superiority over adapalene or benzoyl peroxide alone.     

Split-face clinical and bio-instrumental comparison of 0.1% adapalene and 0.05% tretinoin in facial acne.

BACKGROUND: Adapalene and tretinoin are topical compounds active for treating acne. OBJECTIVE: To compare the efficacity and safety of adapalene 0.1% gel and tretinoin 0.05% gel in moderately severe facial acne using clinical and objective biometrological assessments. Such information is currently lacking in the literature. METHODS: The split-face method was used in 25 acne volunteers for a 6-week treatment. In addition to clinical counts of lesions, the amount of comedones was assessed using computer-assisted morphometry of cyanoacrylate follicular biopsies. The erythema index and squamometry values were used to quantitate skin irritation. RESULTS: The tretinoin formulation brought better comedolysis and clinical improvement than the adapalene formulation. Erythema was transiently more pronounced on the tretinoin-treated side. Squamometry yielded no significant difference between both products. CONCLUSION: Tretinoin 0.05% gel exhibits a greater anti-acne efficacy than adapalene 0.1% gel, although with temperate tolerability.     

异维A酸红霉素凝胶治疗寻常痤疮的多中心随机对照临床研究

目的 比较异维A酸红霉素凝胶与阿达帕林凝胶治疗轻中度寻常痤疮的疗效和安全性。方法 多中心、开放、随机、平行对照研究。按照中国痤疮治疗指南痤疮严重程度标准入选轻、中度（Ⅰ ~ Ⅲ级）寻常痤疮患者192例,纳入疗效分析169例,安全性分析190例。试验组86例,外用异维A酸红霉素凝胶;对照组83例,外用阿达帕林凝胶,均为每晚1次,共用药6周。在基线、治疗2、4和6周时分别记录患者白头粉刺、黑头粉刺、炎性丘疹、脓疱数,评价各时间点患者痤疮严重程度,同时记录皮肤局部耐受性以及其他不良反应。结果 随着治疗时间延长,两组的有效率逐渐提高,总体病情严重程度改善。在治疗6周时,试验组总有效率为51.16%,对照组为40.96%,两组差异无统计学意义（P > 0.05）;但在治疗4周及6周时,试验组患者脓疱及炎性皮损的疗效优于对照组（P < 0.05）,同时试验组痤疮分级较对照组低（P < 0.01）。两组不良反应类似,均表现为局部刺激,可耐受。结论 异维A酸红霉素凝胶治疗轻、中度寻常痤疮总有效率与阿达帕林凝胶类似,对于炎性损害疗效优于阿达帕林凝胶,并且对患者总体严重程度降低更快。     

A comparison of the efficacy and tolerability of adapalene 0·1% gel versus tretinoin 0·025% gel in patients with acne vulgaris: a meta-analysis of five randomized trials

The purpose of this meta-analysis was to determine if adapalene 0·1% gel (Differin®) provided superior efficacy and better tolerability than tretinoin 0·025% gel in the treatment of acne vulgaris. All comparative studies, both published and unpublished, from the United States and Europe, that fulfilled rigorous protocol criteria (multicentre, randomized, investigator-blind) were used. Five comparative studies met these criteria. In total, the meta-analysis evaluated 900 patients (450 treated with adapalene 0·1% gel, 450 treated with tretinoin 0·025% gel) with mild-to-moderate acne from the combined clinical trials. To avoid study bias, the meta-analysis used an intention-to-treat analysis. Statistical methodology for the meta-analysis included analysis of covariance, analysis of variance and Cochran–Mantel–Haenszel test. All statistical tests were two-sided, with the 0·05 probability level used to establish statistical significance, and 95% confidence intervals used to assess equivalence. Adapalene demonstrated equivalent efficacy to tretinoin in terms of reducing total lesion count. Adapalene demonstrated more rapid efficacy, as evidenced by a significant difference in the reduction of inflammatory and total lesions at week 1. Adapalene also demonstrated considerably greater local tolerability at all evaluation periods. The findings from this meta-analysis suggest that adapalene 0·1% gel constitutes a pharmacologic advance over such classic retinoids as tretinoin for the treatment of acne vulgaris.     

Topical retinoids in acne – an evidence‐based overview

Topical retinoids are important tools in the management of acne because they act against comedones and microcomedones and have direct anti‐inflammatory effects. The substances approved for acne treatment comprise tretinoin (all‐trans‐retinoic acid),isotretinoin (13‐cis retinoic acid) as well as the synthetic third‐generation polyaromatic retinoids adapalene and tazarotene,the latter being approved for acne treatment in the US only.Retinaldehyde is used in cosmetic preparations against acne. All topical retinoids are effective as single agents in mild to moderate acne but differ in efficacy and tolerability. Tazarotene 0.1% is more effective than tretinoin 0.025% or 0.1% microsphere gel or adapalene 0.1% gel or cream (EBM‐level 2c). Adapalene 0.1% is equally effective to tretinoin 0.025% or tretinoin microsphere 0.1% gel or tretinoin 0.05% cream or isotretinoin 0.05% gel (EBM‐level 2c). Adapalene 0.1% gel is significantly better tolerated than tazarotene 0.1% gel, tretinoin 0.025% and tretinoin 0.05% gel, tretinoin 0.05% cream,tretinoin microsphere 0.1% gel or isotretinoin 0.05% gel (EBM‐level 2c).The safety profile of topical retinoids differs from their systemic counterparts and is related mainly to local adverse effects, such as erythema, dry‐ness,itching and stinging.The currently available evidence justifies the use of topical retinoids in most types of acne and during maintenance treatment.     

Evaluation of clinical efficacy and safety of adapalene 0·1% gel versus tretinoin 0·025% gel in the treatment of acne vulgaris, with particular reference to the onset of action and impact on quality of life

A randomized, multicentre, investigator-masked study was conducted in 105 patients with mild to moderate acne vulgaris to compare the efficacy and safety of adapalene 0·1% gel with tretinoin 0·025% gel after three months of treatment, with particular emphasis on reduction in inflammatory lesion counts after one week of treatment and impact on quality of life.
  In terms of efficacy, adapalene gel was found to be superior to tretinoin gel after one week of treatment, with respect to reduction in inflammatory lesion counts (32% vs. 17%, respectively; P  = 0·001), total lesion counts (28% vs. 22%, respectively; P  = 0·042) and global severity grade (28% vs. 16%, respectively; P  = 0·001). No significant difference between the two treatments was found after 12 weeks of treatment for any of these variables. Evaluation of facial skin tolerance parameters showed significant differences between the two treatments in favour of adapalene for dryness, erythema, immediate and persistent burning and pruritus for at least one time point. One patient in the adapalene group and three patients in the tretinoin group experienced medical events which lead to discontinuation of treatment (skin irritation; NS). Quality of life scores improved more rapidly in the adapalene group than in the tretinoin group, with significant differences ( P < 0·05) appearing at week 1 for questions related to problems with partners, close friends or relatives and to skin symptoms. There was also a significantly greater improvement in social and leisure activity in the adapalene group at week 12.
  Adapalene 0·1% gel reduced inflammatory and total lesion counts more rapidly than tretinoin 0·025% gel, and was also better tolerated. These differences appear to result in an earlier and greater quality of life improvement for the patients receiving adapalene.     

Multicenter randomized controlled trial on combination therapy with 0.1% adapalene gel and oral antibiotics for acne vulgaris: comparison of the efficacy of adapalene gel alone and in combination with oral faropenem

We conducted a randomized controlled trial in patients with acne vulgaris with moderate to severe inflammatory lesions. The patients were assigned to the following three treatment groups: group A received monotherapy with 0.1% topical adapalene gel for 4 weeks; group B received combination therapy with 0.1% topical adapalene gel and 600 mg oral faropenem for 2 weeks followed by 0.1% topical adapalene gel alone for 2 weeks; and group C received combination therapy with 0.1% topical adapalene gel and 600 mg oral faropenem for 4 weeks. The result of the analysis indicated that the percentage reduction in inflammatory lesion counts after 2 weeks of treatment was significantly higher in groups B and C than in group A (P < 0.05). After 4 weeks of treatment, group C showed significantly higher percentage reduction in inflammatory lesion counts than in groups A and B (P < 0.05), whereas no significant difference was noted between the latter two groups. Adverse reactions included dryness and irritation at the adapalene application sites that were observed in 10.1% of cases (16/158 patients) and diarrhea and loose stool because of oral faropenem that were observed in 7.5% of cases (8/106 patients). Taken together, our results suggest that combination therapy with oral antibiotics and adapalene results in earlier improvement in patients with moderate to severe inflammatory acne compared to the application of adapalene alone, and that 4 weeks of the combination therapy is preferable to 2 weeks of treatment.     

0.1%阿达帕林凝胶和1%克林霉素溶液联合外用治疗寻常痤疮临床观察

目的:比较0.1%阿达帕林凝胶(达芙文)与1%克林霉素磷酸酯溶液(特丽仙)联合外用与特丽仙单用治疗寻常痤疮的疗效和安全性。方法:将300例中至重度寻常痤疮患者分为两组,试验组联合外用达芙文和特丽仙,对照组单用特丽仙,两组共治疗12周。结果:274例患者完成治疗,治疗4周后试验组皮损总数改善显著优于对照组(P<0.05),并维持至12周;治疗8周后试验组炎性皮损和非炎性皮损改善优于对照组(P<0.01),并维持至12周。治疗结束后试验组和对照组的有效率分别为84.40%和72.93%(P<0.05)。试验组局部刺激反应发生率为4.0%,对照组为8.7%。结论:达芙文联合特丽仙治疗中至重度寻常痤疮的疗效比单用特丽仙的效果好。     

A 6-month maintenance therapy with adapalene-benzoyl peroxide gel prevents relapse and continuously improves efficacy among patients with severe acne vulgaris: results of a randomized controlled trial

Background Acne vulgaris is a chronic and frequently recurring disease. A fixed‐dose adapalene‐benzoyl peroxide (adapalene‐BPO) gel is an efficacious and safe acne treatment. Objectives To assess the long‐term effect of adapalene‐BPO on relapse prevention among patients with severe acne after successful initial treatments. Methods This is a multicentre, double‐blind, randomized and controlled study. In total, 243 subjects who had severe acne vulgaris and at least 50% global improvement after a previous 12‐week treatment were randomized into the present study to receive adapalene‐BPO gel or its vehicle once daily for 24 weeks. Results At week 24, compared with vehicle, adapalene‐BPO resulted in significantly higher lesion maintenance success rate (defined as having at least 50% improvement in lesion counts achieved in initial treatment) for all types of lesions (total lesions: 78·9% vs. 45·8%; inflammatory lesions: 78·0% vs. 48·3%; noninflammatory lesions: 78·0% vs. 43·3%; all P < 0·001). Significantly more subjects with adapalene‐BPO than with vehicle had the same or better Investigator’s Global Assessment score at week 24 than at baseline (70·7% vs. 34·2%; P < 0·001). The time when 25% of subjects relapsed was 175 days with adapalene‐BPO and 56 days with vehicle (17 weeks earlier; P < 0·0001). Adapalene‐BPO led to further decrease of lesion counts during the study and 45·7% of subjects were ‘clear’ or ‘almost clear’ at week 24. It was also safe and well tolerated in the study. Conclusions Adapalene‐BPO not only prevents the occurrence of relapse among patients with severe acne, but also continues to reduce disease symptoms during 6 months.     

阿达帕林凝胶治疗寻常痤疮10年回顾

目的 总结阿达帕林凝胶治疗寻常痤疮的临床文献,为临床合理用药提供参考。方法 对阿达帕林凝胶上市10年来国内有关治疗寻常痤疮的疗效及安全性观察的中文文献进行整理和分析。结果 联合用药组疗效高于单用药物组,阿达帕林凝胶组疗效与其他维A酸类药物疗效相当,但高于其他痤疮药物组,不良反应低于其他药物。结论 阿达帕林凝胶治疗轻中度痤疮安全、有效,可单独或联合用药,还可作为维持治疗。     

Prospective, open-label, comparative study of clindamycin 1%/benzoyl peroxide 5% gel with adapalene 0.1% gel in Asian acne patients: efficacy and tolerability

Background  Used as individual agents, topical antibiotics and benzoyl peroxide are known to be effective in treatment of acne. Clindamycin phosphate 1% with benzoyl peroxide 5% (CDP/BPO) is a new combination gel, made by rationale, in that combination drug is more effective than either ingredients used alone. Adapalene 0.1% (ADA) is the third-generation retinoid, shown to be as effective as other topical retinoid with well tolerability.
Objectives  To compare the efficacy and tolerability in combination of CDP/BPO in comparison with ADA in Asian patients with mild to moderate acne vulgaris.
Methods  Total of 69 patients, including 31 patients for CDP/BPO group and 38 for ADA group, with mild to moderate acne vulgaris were enrolled for a 12-week prospective, randomized, open-label comparative study of topical agents. Efficacy was assessed by lesion counts, acne grading system, and global improvement. Adverse events were also evaluated in scale of 0 (none) to 3 (severe).
Results  Both CDP/BPO and ADA were effective in reducing lesion counts and acne severity scale and showed significant global improvement. However, CDP/BPO offered greater efficacy against inflammatory lesions than ADA. Both drugs were well tolerated with minimal adverse drug reactions.
Conclusion  Combination formulation of CDP/BPO and ADA were shown to be both effective in decreasing total, inflammatory, and non-inflammatory lesion counts along with well tolerability in Asian patients with mild to moderate acne vulgaris.

Conflicts of interest

None declared