Evaluation of Acne-induced Hyperpigmentation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 123
- 试验地点
- 25
- 主要终点
- Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle cream in the treatment of moderate acne vulgaris with risk of acne-induced post inflammatory hyperpigmentation (PIH) after 24 weeks of treatment in facial acne participants
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 13 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant with clinical diagnosis of acne vulgaris, defined by:
- •moderate acne on the face (acne Investigator's Global Assessment [IGA] =3); and
- •with minimum of 20 inflammatory lesions and 25 non inflammatory lesions on the face (excluding the nose); and
- •moderate to marked PIH on the face (Overview of Pigmentation Disorders hyperpigmentation scale 4-6); and
- •no more than one acne nodule or cyst (greater than [>] 1 centimeter [cm]) on face (excluding the nose)
- •Participant with any Fitzpatrick Skin Type I to VI (target patient enrollment according to FST)
- •Female participants of childbearing potential must have a negative urine pregnancy test (UPT) at Baseline visit
- •Female participants of childbearing potential must agree to use an adequate and approved method of contraception throughout the study
- •Female participant of non-childbearing potential
- •Other protocol defined inclusion criteria could apply
排除标准
- •Participant with severe acne (IGA > 3)
- •Participant with more than 1 nodule/cyst on the face (excluding the nose)
- •Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne, acne requiring systemic treatment
- •Participant with damaged facial skin that may interfere with study assessments
- •Female participant who is pregnant, lactating or planning a pregnancy during the study
- •Female participant of childbearing potential using combined oral contraceptives approved as acne treatments, in whom the dose has not been stable for at least 6 months prior to the Baseline visit
- •Participant with known impaired hepatic or renal functions
- •Participant with active or chronic skin allergies
研究组 & 干预措施
Trifarotene (CD5789) 50 mcg/g Cream
干预措施: Trifarotene Cream (Drug)
Trifarotene Vehicle Cream
干预措施: Trifarotene Vehicle Cream (Drug)
结局指标
主要结局
Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24
时间窗: Baseline and Week 24
The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \<mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.
次要结局
- Percent Change From Baseline in PIH ODS Scores at Week 24(Baseline and Week 24)
- Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20(Baseline, at Week 12, Week 16 and Week 20)
- Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20(Baseline, at Week 12, Week 16 and Week 20)