A Long Term Study of GK530G 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
- 436
- 试验地点
- 1
- 主要终点
- Local Tolerability (Pruritus)
研究概览
简要总结
This open label study is to determine the safety profile of GK530G in a long-term treatment (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a long-term treatment.
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
- •Men and women at the age of 12 or older at the Screening visit.
- •Those with clinical diagnosis of acne vulgaris with more than 20 non-inflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).
排除标准
- •Those with more than two nodular acne lesions or any cyst.
- •Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
- •Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment
研究组 & 干预措施
GK530G
GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO
干预措施: GK530G (Drug)
结局指标
主要结局
Local Tolerability (Pruritus)
时间窗: 12 months
Highest Severity of Local Tolerability Scores Worse Than Baseline
Local Tolerability (Stinging/Burning)
时间窗: 12 months
Highest Severity of Local Tolerability Scores Worse Than Baseline
Local Tolerability (Erythema)
时间窗: 12 monhths
Highest severity of Local tolerability scores worth than base line
Local Tolerability (Scaling)
时间窗: 12 months
Highest severity of Local tolerability scores worth than base line
Local Tolerability (Dryness)
时间窗: 12 months
Highest Severity of Local Tolerability Scores Worse Than Baseline
次要结局
- Percent Changes From Baseline in Total Lesion Counts(Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12)