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。     

自制复方烟酰胺沙星软膏联合阿达帕林凝胶治疗寻常痤疮的疗效观察

目的:观察自制复方烟酰胺沙星软膏联合0.1%阿达帕林凝胶治疗寻常痤疮的临床疗效。方法:将按入选标准入选的90例寻常痤疮患者随机分为2组,每组45例。治疗组每天早晨、中午各点涂复方烟酰胺沙星软膏1次,晚上薄涂0.1%阿达帕林凝胶1次;对照组每晚薄涂0.1%阿达帕林凝胶1次,疗程均为8周,治疗结束后观察疗效并进行比较。结果:治疗8周疗程结束时治疗组有效率为91.1%,明显高于对照组(71.1%),差异有统计学意义(2=4.66,P0.05)。结论:自制复方烟酰胺沙星软膏联合0.1%阿达帕林凝胶治疗Ⅰ~Ⅱ级轻中度寻常痤疮,可协同作用于炎症性和非炎症性皮损,疗效显著。     

阿达帕林凝胶联合过氧苯甲酰凝胶治疗寻常痤疮的多中心随机对照研究

目的评价阿达帕林凝胶联合过氧苯甲酰凝胶治疗轻中度寻常痤疮的疗效和安全性。方法随机、多中心、开放、平行对照研究。按照痤疮严重程度国际改良标准入选轻、中度寻常痤疮患者。试验组早晨外用5%过氧苯甲酰凝胶1次,晚睡前外用0.1%阿达帕林凝胶1次;对照组仅晚睡前外用0.1%阿达帕林凝胶1次。共用药12周,在基线、2、4、8和12周时记录炎性皮损、非炎性皮损和总皮损数,皮肤局部刺激反应如红斑、脱屑、干燥、烧灼/刺痛的评分,以及其他不良反应。结果3个中心共入选150例患者。试验组、对照组的总有效率在第8周分别为74.6%和56.7%(P<0.05);在第12周时分别为81.3%和68.9%(P>0.05)。局部刺激反应评分除烧灼/刺痛在第4、8周时两组间的差异有显著性外,其余差异均无显著性。另外,两组各有2例发生接触性皮炎。结论0.1%阿达帕林凝胶合用5%过氧苯甲酰治疗轻中度寻常痤疮较0.1%阿达帕林凝胶单用疗效显著,见效快,病程短,未增加不良反应。     

夫西地酸乳膏联合阿达帕林凝胶治疗寻常痤疮的临床观察

目的评价2%夫西地酸软膏联合0.1%阿达帕林凝胶治疗轻、中度寻常痤疮的临床疗效及安全性。方法寻常痤疮246例,随机分为3组,治疗组98例,采用2%夫西地酸软膏联合0.1%阿达帕林凝胶治疗;对照A组81例,采用1%克林霉素磷酸酯凝胶联合0.1%阿达帕林治疗;对照B组67例,单独使用0.1%阿达帕林凝胶治疗。均连用8周,分别在治疗后第2,4,8周末观察疗效并评价安全性。结果在治疗后第8周,治疗组有效率93.88%,与对照A组(81.48%)相比差异有统计学意义(P=0.010);治疗组Ⅲ级痤疮的有效率93.02%,与对照A组(69.70%)相比差异有统计学意义(P=0.007);疗程结束后,治疗组复发5例,复发率5.10%,远低于2个对照组。单独外用阿达帕林疗效均欠佳,且复发率较高。在治疗过程中,3组均未见明显不良反应。结论 2%夫西地酸软膏联合0.1%阿达帕林凝胶治疗轻、中度寻常痤疮具有疗效较好、复发率低、不良反应少等优点,是较理想的治疗方案。     

普济消毒饮加减联合外用阿达帕林凝胶治疗寻常型痤疮疗效观察

目的观察普济消毒饮加味联合外用阿达帕林凝胶治疗寻常痤疮的临床疗效。方法将60例患者随机分成观察组和对照组,观察组采用口服中药普济消毒饮加减,睡前外用阿达帕林凝胶;对照组仅睡前外用阿达帕林凝胶,观察临床疗效及不良反应。结果中药普济消毒饮加减联合外用阿达帕林凝胶治疗寻常痤疮,治疗8周有效率70.00%,明显优于对照组(对照组40.00%);治疗12周,观察组有效率83.33%,与对照组(有效率60.00%)相比,差异有统计学意义(P0.05)。结论中药普济消毒饮加减联合外用阿达帕林凝胶治疗寻常痤疮疗效显著。     

皮脂腺及皮下脂肪疾病

20 0 4 10 97　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/蔡林(北大人民医院皮肤科)…∥临床皮肤科杂志.- 2 0 0 3,32 (10 ) .- 6 14～6 15试验组150例于每日早晚各外涂1%克林霉素磷酸脂溶液(特丽仙) 1次,晚上于睡前外涂0 .1%阿达帕林凝胶(达芙文) 1次;对照组150例每日早晚各外涂特丽仙1次,连续用药12周判效。结果两组基本痊愈率分别为6 2 .4 0 %、4 5.11% ,差异有显著性(P <0 .0 1) ,有效率分别为84 .4 0 %、72 .93% (P <0 .0 5)。说明联合用药在消除痤疮的非炎性损害及炎性损害方面有协同作用。不良反应表现为局…     

复方多粘菌素B软膏联合阿达帕林凝胶治疗中度痤疮疗效观察

目的观察复方多粘菌素B软膏联合阿达帕林凝胶治疗寻常型痤疮的疗效和安全性。方法将101例中度痤疮患者随机分为两组,治疗组55例采用复方多粘菌素B软膏联合阿达帕林凝胶治疗,阿达帕林凝胶每晚1次,复方多粘菌素B软膏2次/d,疗程为4周;对照组46例,每晚1次外用阿达帕林凝胶,莫匹罗星乳膏2次/d,连续4周为一个疗程。结果治疗组和对照组有效率分别为83.6%和65.2%,有效率存在明显差异(P0.05)。治疗组不良反应明显少于对照组。结论复方多粘菌素B软膏联合阿达帕林凝胶治疗寻常型痤疮可明显提高疗效,减少不良反应,值得临床推广。     

阿达帕林凝胶联合冷敷修复贴治疗面部Ⅰ、Ⅱ级痤疮的疗效观察

目的探讨在Ⅰ、Ⅱ级痤疮的治疗及维持治疗上,阿达帕林凝胶联合冷敷修复贴治疗的作用。方法将入选的83例患者随机分为3组,阿达帕林凝胶联合冷敷修复贴为A组;单用阿达帕林凝胶为B组;单用冷敷修复贴为C组。3组病人均观察8周,根据治疗前后皮损减少程度来判定疗效。结果治疗4周后,A组和B组患者皮损减少显著优于C组(P0.05),并维持至8周。治疗结束后3组有效率为78.57%、70.37%、28.57%。结论在Ⅰ、Ⅱ级痤疮的治疗及维持治疗上,单独应用阿达帕林凝胶有良好的效果,但联合冷敷修复贴治疗后可以明显减少不良反应,增加患者依从性,从而取得更好的疗效。     

阿达帕林凝胶治疗寻常痤疮60例观察

临床资料:1998年10月～2001年5月笔者采用0.1%阿达帕林凝胶治疗寻常痤疮60例,其中男45例,女15例,平均年龄(24.5±4.5)岁(18～30岁)。所有患者均为轻度至中度面部寻常痤疮。治疗前每例患者平均炎性皮损数为22.5个,平均非炎性皮损数为40.1个,平均总皮损数为62.6个。治疗方法:每晚清洁患处,待干燥后将0.1%阿达帕林凝胶涂于痤疮部位,疗程8周。在初诊及治疗后2、4、8周复诊时详细填写临床观察表格,记录疗效指标及所有不良反应。在用药8周末,根据治疗后炎性皮损和非炎性皮损总数减少的数量评价疗效。治愈及基本治愈为皮损总数减少90%或以上;显效为…     

阿奇霉素联合阿达帕林凝胶治疗中重度寻常痤疮临床疗效观察

目的：观察阿奇霉素联合阿达帕林凝胶治疗中重度寻常痤疮的临床疗效及安全性。方法：79例患者随机分为两组,治疗组采用阿奇霉素联合阿达帕林凝胶治疗,对照组四环素联合阿达帕林凝胶治疗。结果：治疗8、12周后联合组总有效率高于对照组（均P〈0.05）,不良反应发生率低。结论：阿奇霉素联合阿达帕林凝胶治疗中重度寻常痤疮疗效高,安全性好。     

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.     

Control of microcomedone formation throughout a maintenance treatment with adapalene gel, 0.1%

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.     

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.     

Effect of sequential application of topical adapalene and clindamycin phosphate in the treatment of Japanese patients with acne vulgaris

The efficacy of combined therapy with a retinoid and antibiotic for Japanese patients with acne vulgaris remains to be established. Further, maintenance strategies limiting the use of topical retinoids must be identified. The objectives of this study are to determine the efficacy of sequential application of topical adapalene and clindamycin phosphate and to assess the impact of this regimen on patients' quality of life. Sixty-six patients were recruited. The regimen comprised two phases. For the 4-week initial treatment, 1% clindamycin phosphate gel was applied twice daily and 0.1% adapalene gel, once. In the 4-week maintenance phase, patients were randomly assigned to the OD group (adapalene applied once daily) or the TW group (adapalene applied once daily on 2 days per week). The acne severity score, lesion counts, microcomedone count, and sebum amount were measured. Quality of life (QOL) was assessed using Skindex-16. All parameters improved significantly by week 4 of initial treatment. No statistically significant differences were found in the improvement of clinical findings between the groups. All QOL scores improved significantly and did not significantly differ between the groups. Our regimen may enable clinical control of acne in Japanese patients and improve their QOL. For limiting retinoid use, weekly application of adapalene during maintenance is suitable.     

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.     

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.     

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.     

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.