A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to "Clear" or "Almost Clear"
研究概览
简要总结
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
详细描述
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female at least 2 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)
- •Nonimmunocompromized male or female who failed to respond adequately to other topical prescription treatment for AD or for whom those treatments are not advisable
- •Subjects must be willing to comply with study instructions and return to the clinic for required visits; subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing
排除标准
- •Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
- •Active cutaneous bacterial or viral infection in any treatment area at Baseline (eg, clinically infected AD)
- •Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline, which would interfere with evaluations
- •History of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or ichthyosis (other than ichthyosis vulgaris)
研究组 & 干预措施
IDP-124 Lotion
IDP-124 Lotion, twice-daily application
干预措施: IDP-124 Lotion (Drug)
IDP-124 Vehicle Lotion
IDP-124 Vehicle Lotion, twice-daily application
干预措施: IDP-124 Vehicle Lotion (Drug)
结局指标
主要结局
Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to "Clear" or "Almost Clear"
时间窗: Baseline to Week 6
Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.
次要结局
- Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to "Clear" or "Almost Clear"(Baseline to Week 10)
- Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to "None" or "Mild"(Baseline to Week 2)
- Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75(Baseline to Week 10)