A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 741
- 试验地点
- 34
- 主要终点
- Non-inflammatory Lesion Counts
研究概览
简要总结
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
详细描述
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 9 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at least 9 years of age and older.
- •Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).
- •Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.
- •Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than
- •Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than
- •Subjects with 2 or fewer facial nodules
排除标准
- •Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
- •Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis, eczema.
- •Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
- •Subjects with a facial beard or mustache that could interfere with the study assessments.
- •Subjects with more than 2 facial nodules.
- •Evidence or history of cosmetic-related acne.
研究组 & 干预措施
IDP-126 Gel
Gel
干预措施: IDP-126 Gel (Drug)
IDP-126 Component A
Component A
干预措施: IDP-126 Component A (Drug)
IDP-126 Component B
Component B
干预措施: IDP-126 Component B (Drug)
IDP-126 Component C
Component C
干预措施: IDP-126 Component C (Drug)
IDP-126 Vehicle Gel
Vehicle Gel
干预措施: IDP-126 Vehicle Gel (Drug)
结局指标
主要结局
Non-inflammatory Lesion Counts
时间窗: Baseline to Week 12
Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
Percentage of Participants With Success on the Evaluator's Global Severity Score
时间窗: Baseline to Week 12
Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Inflammatory Lesion Counts
时间窗: Baseline to Week 12
Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
次要结局
- Inflammatory Lesion Count Changes at Week 2, 4, and 8(Baseline to Week 2, 4, 8)
- Non-inflammatory Lesion Count Changes at Week 2, 4, and 8(Baseline to Week 2, 4, 8)
- Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8(Baseline to Week 2, 4, 8)
- Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8(Baseline to Week 2, 4, 8)
- Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8(Baseline to Week 2, 4, and 8)
- Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8(Baseline to Week 2, 4, and 8)