A Multicenter, Randomized, Double-Blind, 12-Week Study Of The Safety And Efficacy Of AN2728 Versus AN2728 Vehicle In The Treatment Of Patients With Mild-To-Moderate Plaque-Type Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 68
- 试验地点
- 10
- 主要终点
- Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84
研究概览
简要总结
The purpose of this study is to determine whether AN2728 topical ointment is a safe and effective treatment for mild-to-moderate plaque-type psoriasis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of stable mild-to-moderate plaque-type psoriasis involving 2-35% of total body surface area (BSA) excluding face, scalp, and genitals
- •Willingness and ability to apply study medication as directed, comply with study instructions, and commit to attending all study visits
- •Women of childbearing potential must agree to use contraception for the entire study period
排除标准
- •Any dermatological conditions that could interfere with clinical evaluations
- •Concurrent or recent use of certain topical or systemic medications without a sufficient washout period
- •Significant confounding conditions as assessed by study doctor
- •Participated in any other trial of an investigational drug within 30 days or participation in a research study concurrent with this study
- •Use of lithium- or hydroxychloroquine-containing products (e.g., Plaquenil)
- •Use of a beta-blocking medication (e.g., propranolol) if the dose has not been stabilized for at least 3 months
- •Pregnancy or lactation
研究组 & 干预措施
AN2728 ointment, 2%
AN2728 ointment, 2%
干预措施: AN2728 ointment, 2% (Drug)
Ointment Vehicle
Ointment Vehicle
干预措施: Ointment Vehicle (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84
时间窗: Day 84
PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 84.
次要结局
- Number of Participants With Local Tolerability Symptoms: Pruritus(Baseline (Day 1) up to Day 84)
- Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70(Day 14, Day 28, Day 42, Day 56, Day 70)
- Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84(Baseline (Day 1), Day 84)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline (Day 1) up to Day 84)
- Number of Treatment-Emergent Adverse Events (TEAEs) by Severity(Baseline (Day 1) up to Day 84)
- Number of Participants With Local Tolerability Symptoms: Burning/Stinging(Baseline (Day 1) up to Day 84)