NCT03250624已完成2 期
Safety and Efficacy of CD5024 0.3% Cream in Subjects With Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 63
- 试验地点
- 5
- 主要终点
- Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43
研究概览
简要总结
Exploratory, multi-centric, randomized, vehicle-controlled, investigator-blind, parallel group study, involved participants with chronic lesions of Atopic Dermatitis (AD) to evaluate the local and systemic safety of CD5024 0.3% cream over a 6-week treatment period compared to its vehicle.
详细描述
Study application was performed once daily, 7 days a week for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant was a male or female aged 18 to 60 years old inclusive at Screening.
- •The participant presented with a total body surface area (tBSA) less than or equal to (>=) 2 square meter (m^2) at Screening.
- •The participant had atopic dermatitis for at least 6 months prior to Day
- •The clinical diagnosis of atopic dermatitis must be confirmed with the criteria of Hanifin and Rajka at the screening visit.
- •Atopic dermatitis must be stable for at least one month before the screening visit (according to participant).
- •The participant had a Body Surface Area (BSA) affected by AD ranging from 1% inclusive to 10% inclusive at Day 1, excluding scalp and genitals.
- •The participant had an overall Investigator's Global Assessment (IGA) score of 3 (moderate) at Day 1;
排除标准
- •The participant was a pregnant female, is breastfeeding or intends to conceive a child during the study,
- •The participant had any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results (e.g. extensive scaring or pigmented lesion in a treated area), and/or put the participant at significant risk according to Investigator's judgment if he/she participates in the clinical trial (e.g. active cancer, AIDS, insulin-dependent diabetes...) at Screening or Day
- •The participant presented with an acute flare of AD at Day
- •The participant had active cutaneous bacterial or viral infection in any treated area at baseline (e.g. clinically infected AD) at Screening or Day
- •The participant had a history of confounding skin condition (e.g. psoriasis, erythroderma) or a history of Netherton syndrome at Screening.
- •The participant had a past history of serious persistent neurological disorders such as seizures, multiple sclerosis, or neurological signs or symptoms at Screening.
研究组 & 干预措施
CD5024 0.3% cream
Experimental
干预措施: CD5024 0.3% cream (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43
时间窗: Baseline, Day 43
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum), with the higher scores indicated the worse severity of AD. All missing values were imputed by Last Observation Carried Forward (LOCF).
次要结局
- Percent Change From Baseline in EASI at Each Visit(Baseline, Days 8,15, 22, 29, 36 and 43)
- Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43(Baseline, Day 43)
- Percent Change From Baseline in Total Sum Score (TSS) at Each Visit(Baseline, Days 8, 15, 22, 29, 36 and 43)
- Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit(Baseline, Days 8, 15, 22, 29, 36 and 43)
- Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)(Days 8, 15, 22, 29, 36 and 43)
- Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit(Baseline, Weeks 1, 2, 3, 4, 5 and 6)
研究者
研究点 (5)
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