A Long-term Safety and Efficacy Study of a Fixed Combination of Adapalene 0.1% and Benzoyl Peroxide 2.5% (Adapalene and Benzoyl Peroxide Topical Gel) Gel in Subjects With Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 452
- 试验地点
- 1
- 主要终点
- Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6
研究概览
简要总结
This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.
Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.
Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of acne vulgaris with facial involvement.
- •A minimum of 20 but not more than 50 Inflammatory lesions.
- •A minimum of 30 but not more than 100 Noninflammatory lesions.
排除标准
- •Subjects with presence of nodules or cysts.
- •Acne conglobate, acne fulminans, secondary acne, or severe acne.
- •Underlying diseases that required the use of interfering topical or systemic therapy.
- •Use of prohibited medications prior to the study unless appropriate washout period was documented.
研究组 & 干预措施
Adapalene/Benzoyl Peroxide
Participants were treated with adapalene 0.1 percent (%) [weight by weight (W/W)] and benzoyl peroxide 2.5 percent (%) (W/W) gel topically to the face and trunk area once daily in the evening.
干预措施: Adapalene/Benzoyl Peroxide (Drug)
结局指标
主要结局
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6
时间窗: At Month 6
Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse.
Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF
时间窗: Baseline, Month 12 LOCF
Percent change in inflammatory, noninflammatory and total lesions at Month 12 was measured from baseline lesions. The noninflammatory lesion count was the sum of open comedones (a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead) and closed comedones (a mass of sebaceous material that is impacted behind a closed follicular orifice (whitehead). The inflammatory lesion count was the sum of papules (a small, solid elevation less than 1.0 cm in diameter) and pustules (a small, circumscribed elevation of the skin that contains yellow-white exudate). The total lesion count was the sum of inflammatory and noninflammatory lesions. Missing adapalene and benzoyl peroxide data were imputed using last observation carried forward (LOCF).
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12
时间窗: At Month 12
Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse.
次要结局
- Number of Participants With Local Tolerability Assessment For Erythema(Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12)
- Number of Participants With Local Tolerability Assessment For Scaling(Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12)
- Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE)(Baseline up to Month 14)
- Number of Participants With Local Tolerability Assessment For Dryness(Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12)
- Number of Participants With Local Tolerability Assessment For Stinging/Burning(Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12)
- Number of Participants With Clinically Significant Abnormal Laboratory Parameters(Baseline up to Month 14)