A Multicenter, Randomized, Double Blind, Placebo-controlled, Two-arm, Phase II Clinical study to evaluate Safety, Tolerability and Efficacy of Topical 1% AKP-11 in Atopic Dermatitis Participants.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- 1. Percentage change in Scoring of Atopic Dermatitis (SCORAD).
研究概览
简要总结
STUDY TITLE: A Multicenter, Randomized, Double Blind, Placebo-controlled, Two-arm, Phase II Clinical study to evaluate Safety, Tolerability and Efficacy of Topical 1% AKP-11 in Atopic Dermatitis Participants.
**Objective:**To determine the safety, tolerability, and efficacy of topical 1% AKP-11 ointment when applied in Atopic Dermatitis Participants and to demonstrate the active treatment over placebo.
End points:
| Primary Endpoints |
1. Percentage change in Scoring of Atopic Dermatitis (SCORAD) from baseline (Day 1) to EOT.
2. Percentage change in Eczema Area and Severity Index (EASI) from baseline (Day 1) to EOT.
3. Proportion of participants with an improvement of pruritus on VAS scale from baseline (Day 1) to EOT.
Secondary Endpoints
1. Proportion of participants with an Investigator Global Assessment (IGA) success defined as:
· ≥2 point improvement from baseline (Day 1) at Day 7 and 14.
2. Safety of AKP-11 ointment
**Number of subjects:**A total of 150 participants will be randomized in 1:1 proportion as 75:75 participants in each arm (1% AKP-11 and Placebo respectively)
**Study Duration:**21 Days
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with Atopic Dermatitis as per Hanifin and Rajika method will be taken in the study.
- •Participants with Diagnosis of Mild to Moderate Atopic Dermatitis (AD) condition as per Scoring of Atopic Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI) will be included in the study.
- •Participants with at least one Atopic Dermatitis spot with baseline score of pruritus as high moderate to severe itch (VAS ≥6cm) with average pruritus of (VAS ≥6cm) over 3 consecutive days prior to baseline visit.
- •Participants who will be able to provide written informed consent prior to the performance of any study specific procedures.
排除标准
- •Participants with history of allergy or hypersensitivity to any of the ingredients such as AK-119 free base, Propylene glycol, Stearic acid, Paraffin oil, Cetyl alcohol, Petrolatum jelly and Glyceryl monostearate.
- •Participants with any skin condition other than Atopic dermatitis, such as cutaneous infections, skin cancer, significant sun damage or an inherited skin disorder that in the opinion of the Investigator could interfere with the evaluation of the trial medication.
- •Participants suspected with COVID-19 symptoms.
- •Topical treatment within 2 weeks prior to commencement of study treatment including: topical corticosteroids; topical calcineurin inhibitor, antihistamine or any other topical treatments that in the opinion of the investigator could modify disease activity.
结局指标
主要结局
1. Percentage change in Scoring of Atopic Dermatitis (SCORAD).
时间窗: Baseline (Day 1) to EOT
2. Percentage change in Eczema Area and Severity Index (EASI).
时间窗: Baseline (Day 1) to EOT
3. Proportion of participants with an improvement of pruritus on VAS scale.
时间窗: Baseline (Day 1) to EOT
次要结局
- 1. Proportion of participants with an Investigator Global Assessment (IGA) success defined as:(• ≥2 point improvement)