A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Comparing Dapsone 5% Gel (SEEGPharm SA) to Aczone® and Both Active Treatments Compared to Placebo (Vehicle) in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,361
- 试验地点
- 1
- 主要终点
- Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts
研究概览
简要总结
Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris.
详细描述
Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris for 84 days in male and female subjects age 12-40.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male or non-pregnant females aged ≥ 12 and ≤ 40 years of age with a clinical diagnosis of acne vulgaris.
- •Informed Consent/Assent: For subjects 12 to 17 years of age inclusive must have provided Institutional Review Board (IRB) approved written assent that must be accompanied by an IRB approved written consent from the subject's legally acceptable representatives (i.e., parent or guardian). In addition, all subjects or their legally acceptable representatives must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization.
- •On the face, subjects must have ≥ 20 inflammatory lesions (i.e., papules and pustules), AND ≥ 25 non-inflammatory lesions (open and closed comedones) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment and evaluation, all lesions on the face should be counted, including those on the nose. Subjects may have acne lesions on other areas of the body (e.g., back, chest, and arms) which should be excluded from the count, treatment and the IGA evaluation.
- •Subjects must have an acne severity grade of 3 or 4 per the IGA
- •Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period other than the study drug.
排除标准
- •Prior or current concomitant therapies that would interfere with assessments in the study.
- •Prior or current concomitant therapies skin conditions that would interfere with assessments in the study.
- •Prior, current or planned procedures that would interfere with assessments in the study.
- •Current or planned activities that would interfere with assessment in the study.
- •Subjects who have a Baseline local skin site reaction score of 3 [severe (marked/intense)] for any signs and/or symptoms of irritation as scored using the local skin site reaction scores.
研究组 & 干预措施
Dapsone 5.0% Gel (Allergan)
Dapsone 5.0% Gel applied twice daily for 84 days
干预措施: Dapsone 5.0% Gel (Allergan) (Drug)
Dapsone 5.0% Gel (SEEGPharm)
Dapsone 5.0% Gel applied twice daily for 84 days
干预措施: Dapsone 5.0% Gel (SEEGPharm) (Drug)
Placebo
Vehicle of Experimental Gel applied twice daily for 84 days
干预措施: Placebo (Other)
结局指标
主要结局
Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts
时间窗: Treatment Days: 84 days of dosing
To compare Dapsone 5% Gel (SEEGPharm) to Aczone® (Allergan's Dapsone 5% Gel) to the Placebo-Vehicle control with respect to the mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts, from Baseline (Visit 1/ Day1) to End-of-Treatment (EOT)
次要结局
- Clinical Success: Proportion of subjects with a clinical response of "success"(12 Weeks)