Stein Gold Linda, Weiss Jonathan, Rueda Maria Jose, Liu Hong, Tanghetti Emil
Department of Dermatology, Henry Ford Medical Center, Detroit, MI, USA.
Henry Ford Medical Group, 6530 Farmington Rd, West Bloomfield, MI, 48322, USA.
Am J Clin Dermatol. 2016 Jun;17(3):293-303. doi: 10.1007/s40257-016-0178-4.
A need exists for topical treatments in managing more severe inflammatory acne.
The objectives of this study were to evaluate the efficacy and safety of adapalene 0.3 %/benzoyl peroxide 2.5 % (0.3 % A/BPO) topical gel in subjects with moderate and severe inflammatory acne.
This was a multicenter, randomized, double-blind, parallel-group study. Randomization was stratified by acne severity (50 % moderate and 50 % severe). Subjects received 0.3 % A/BPO, 0.1 % A/BPO (benchmark), or vehicle (comparator) once daily for 12 weeks. Co-primary efficacy endpoints were success rate at week 12 (the percentage of subjects rated 'clear' or 'almost clear' with at least a 2-grade improvement on Investigator's Global Assessment [IGA]) and change in inflammatory (IN) and noninflammatory (NIN) lesion counts from baseline to week 12. Secondary efficacy endpoints were percent changes in IN and NIN lesion counts. Safety endpoints were incidence of adverse events (AEs) and local tolerability signs/symptoms.
A total of 503 subjects were randomized: 217, 217, and 69 subjects in the 0.3 % A/BPO, 0.1 % A/BPO, and vehicle groups, respectively. For success rate (subjects rated 'clear' or 'almost clear' with ≥2-grade improvement in IGA), 0.3 % A/BPO was superior to vehicle, with a treatment difference of 22.7 % (33.7 vs. 11.0 %; 95 % confidence interval [CI] 12.8-32.6, p < 0.001). At week 12, 0.3 % A/BPO was superior to vehicle for mean reduction from baseline in IN (27.0 vs. 14.4) and NIN lesion counts (40.2 vs. 18.5), as well as for percentage reduction from baseline in IN (68.7 vs. 39.2 %) and NIN lesion counts (68.3 vs. 37.4 %) (all p < 0.001). Among subjects with severe inflammatory acne (IGA = 4), 0.1 % A/BPO did not reach statistical significance for success rate compared with vehicle (p = 0.443), whereas 0.3 % A/BPO demonstrated significantly greater efficacy (p = 0.029, requiring ≥3-point IGA improvement). Additionally, 0.3 % A/BPO was safe and well-tolerated.
Results of this clinical trial demonstrate the significantly greater efficacy of adapalene 0.3 % A/BPO topical gel compared with vehicle as well as a good safety profile in the treatment of moderate to severe inflammatory non-nodulocystic acne, which increases patients' treatment options. CLINICALTRIALS.
NCT01880320.
在治疗更严重的炎性痤疮方面，存在对局部治疗的需求。
本研究的目的是评估0.3%阿达帕林/2.5%过氧化苯甲酰（0.3%A/BPO）外用凝胶在中度和重度炎性痤疮患者中的疗效和安全性。
这是一项多中心、随机、双盲、平行组研究。随机分组按痤疮严重程度分层（50%为中度，50%为重度）。受试者每天接受一次0.3%A/BPO、0.1%A/BPO（对照）或赋形剂（对照）治疗，持续12周。共同主要疗效终点为第12周的成功率（根据研究者整体评估[IGA]，被评为“清除”或“几乎清除”且改善至少2级的受试者百分比）以及从基线到第12周炎性（IN）和非炎性（NIN）皮损计数的变化。次要疗效终点为IN和NIN皮损计数的百分比变化。安全性终点为不良事件（AE）的发生率和局部耐受性体征/症状。
共有503名受试者被随机分组：0.3%A/BPO组、0.1%A/BPO组和赋形剂组分别有217名、217名和69名受试者。对于成功率（根据IGA被评为“清除”或“几乎清除”且改善≥2级的受试者），0.3%A/BPO优于赋形剂，治疗差异为22.7%（33.7%对11.0%；95%置信区间[CI]12.8 - 32.6，p < 0.001）。在第12周，0.3%A/BPO在IN（27.0对14.4）和NIN皮损计数从基线的平均减少量方面优于赋形剂，以及在IN（68.7%对39.2%）和NIN皮损计数从基线的减少百分比方面也优于赋形剂（所有p < 0.001）。在重度炎性痤疮（IGA = 4）患者中，0.1%A/BPO与赋形剂相比，成功率未达到统计学显著性（p = 0.443），而0.3%A/BPO显示出显著更高的疗效（p = 0.029，要求IGA改善≥3分）。此外，0.3%A/BPO安全且耐受性良好。
该临床试验结果表明，0.3%A/BPO外用凝胶在治疗中度至重度炎性非结节囊肿性痤疮方面与赋形剂相比疗效显著更高，且安全性良好，这增加了患者的治疗选择。临床试验。
NCT01880320
