NCT04214639已完成3 期
A Phase 3, 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 13
- 主要终点
- Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
研究概览
简要总结
This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 —（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 Evaluator's Global Severity Score (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 30, but no more than
- •Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 35, but no more than
- •Subjects with 2 or fewer facial nodules.
排除标准
- •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 more than 2 facial nodules.
- •Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
- •Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks immediately preceding study entry; subjects treated with estrogens 12 or more consecutive weeks immediately prior to study entry need not be excluded unless the subject expects to change dose, drug or discontinue estrogen use during the study.
- •Treatment of any type of cancer within the last 6 months, with the exception of complete surgical excision of skin cancer outside the treatment area.
- •Subjects who have not undergone specified washout period(s) for topical preparations/physical treatments used on the face or subjects who require the concurrent use in the treatment area.
- •Subjects who have not undergone specified washout period(s) for systemic medications or subjects who require the concurrent use of systemic medications.
- •Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.
研究组 & 干预措施
IDP-126 Gel
Experimental
干预措施: IDP-126 Gel (Drug)
IDP-126 Vehicle Gel
Placebo Comparator
干预措施: IDP-126 Vehicle Gel (Drug)
结局指标
主要结局
Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
时间窗: 12 weeks
Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts
时间窗: 12 weeks
Percentage of Participants With Success on the Evaluator's Global Severity Score
时间窗: 12 weeks
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.
次要结局
- Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12(12 weeks)
- Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12(Baseline to Week 4, 8, 12)
- Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12(Baseline to Week 4, 8, 12)
研究者
研究点 (13)
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