一项评估每日或每日两次使用SB204治疗寻常痤疮的疗效、耐受性和安全性的2期随机载体对照研究结果

Results of a Phase 2, Randomized,Vehicle-Controlled Study Evaluating the Efficacy,Tolerability, and Safety of Daily or Twice Daily SB204 for the Treatment of Acne Vulgaris.

作者信息

Eichenfield Lawrence F, Gold Linda Stein, Nahm Walter K, Cook-Bolden Fran E, Pariser David M

出版信息

J Drugs Dermatol. 2016 Dec 1;15(12):1496-15027.

Abstract

OBJECTIVE

This randomized, double-blind, placebo-controlled, Phase 2 study compared efficacy, tolerability, and safety of SB204 once or twice daily to vehicle in the treatment of acne vulgaris.

METHODS

Eligible subjects were to be between 12 and 40 years old, have facial acne vulgaris with 25 to 70 non-inflammatory lesions, 20 to 40 inflammatory lesions, no more than 2 nodules, and a baseline Investigator's Global Assessment (IGA) score of moderate or severe. The co-primary efficacy endpoints were the absolute change in inflammatory and non-inflammatory lesion counts and IGA success rate (baseline to week 12). Safety assessments included reported adverse events (AEs), physical examinations, and laboratory testing. Tolerability was evaluated by the investigators based on the occurrence and severity of erythema, scaling, dryness, pruritus, and burning/stinging.

RESULTS

A total of 213 subjects were randomized: 27 subjects to vehicle once daily; 29 subjects to vehicle twice daily; 53 subjects to SB204 2% twice daily; 52 subjects to SB204 4% once daily; and 52 subjects to SB204 4% twice daily. When compared to vehicle, treatment with all 3 SB204 regimens significantly reduced the absolute inflammatory lesion count and SB204 4% once daily reduced the absolute non-inflammatory lesion count. Treatment with SB204 4% once daily demonstrated a significant reduction in percent inflammatory lesions by week 4. There were no significant differences in the IGA success rates between groups at the end of treatment. All treatment regimens of SB204 were found to be safe and well tolerated.

CONCLUSIONS

When compared to vehicle, SB204 2% and SB204 4% significantly decreased the absolute inflammatory lesion count and SB204 4% once daily also significantly decreased the absolute non-inflammatory lesion count in subjects with acne vulgaris treated for 12 weeks. Treatment with SB204 2% and 4% was found to be safe and well tolerated. J Drugs Dermatol. 2016;15(12):1496-1502.

摘要

目的

本随机、双盲、安慰剂对照的2期研究比较了SB204每日一次或两次与赋形剂治疗寻常痤疮的疗效、耐受性和安全性。

方法

符合条件的受试者年龄在12至40岁之间，面部患有寻常痤疮，有25至70个非炎性皮损、20至40个炎性皮损、不超过2个结节，且基线研究者整体评估（IGA）评分为中度或重度。共同主要疗效终点为炎性和非炎性皮损计数的绝对变化以及IGA成功率（从基线至第12周）。安全性评估包括报告的不良事件（AE）、体格检查和实验室检测。研究者根据红斑、脱屑、干燥、瘙痒和灼痛/刺痛的发生情况和严重程度评估耐受性。

结果

共有213名受试者被随机分组：27名受试者接受每日一次赋形剂治疗；29名受试者接受每日两次赋形剂治疗；53名受试者接受2%SB204每日两次治疗；52名受试者接受4%SB204每日一次治疗；52名受试者接受4%SB204每日两次治疗。与赋形剂相比，所有3种SB204治疗方案均显著降低了炎性皮损的绝对计数，且4%SB204每日一次治疗降低了非炎性皮损的绝对计数。4%SB204每日一次治疗在第4周时炎性皮损百分比显著降低。治疗结束时，各组间IGA成功率无显著差异。所有SB204治疗方案均被发现安全且耐受性良好。