A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Clinical Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel (0.3% Adapalene/2.5% BPO), in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 686
- 试验地点
- 42
- 主要终点
- Absolute Change From Baseline to Week 12 in Lesion Counts.
研究概览
简要总结
The safety and efficacy of once daily application of IDP 126 Gel will be compared to Epiduo® Forte and IDP-126 Vehicle Gel.
详细描述
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 with Epiduo® Forte gel and IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study, subjects must be at least 12 years of age and have a clinical diagnosis of moderate to severe acne (defined as an Evaluator's Global Severity Score [EGSS] of 3 or 4), presenting with 30-100 inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-inflammatory facial lesions (open and closed comedones), and ≤ 2 facial nodules.
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
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female at least 12 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 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
IDP-126 Gel (clindamycin phosphate 1.2%, BPO 3.1%, and adapalene 0.15%), applied topically to the face once daily for 12 weeks
干预措施: IDP-126 Gel (Drug)
IDP-126 Vehicle Gel
IDP-126 Vehicle Gel applied once daily for 12 weeks
干预措施: IDP-126 Vehicle Gel (Drug)
Epiduo® Forte Gel
Epiduo® Forte Gel (adapalene 0.3%/ 2.5% BPO) applied once daily for 12 weeks
干预措施: Epiduo® Forte Gel (Drug)
结局指标
主要结局
Absolute Change From Baseline to Week 12 in Lesion Counts.
时间窗: Baseline to Week 12
Inflammatory and non-inflammatory lesion counts were collected starting from the Baseline Visit.
Percentage of Subjects Who Achieve at Least a Two-grade Reduction From Baseline and Are "Clear" or "Almost Clear" at Week 12 in the Evaluator's Global Severity Score.
时间窗: Baseline to 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
未报告次要终点