NCT03351777Unknown2 期
Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis
Realm Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年12月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI)
研究概览
简要总结
The purpose of this study is to determine whether PR022 Topical Gels are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 18 to 65 years of age
- •EASI score ≤ 21 at baseline
- •Diagnosis of mild-to-moderate (grade 2 or 3) AD according to the ISGA scale at Baseline
- •BSA affected by AD: 5% to 20% at start of treatment
- •Willing and able to apply study treatments as directed, comply with study instructions, and commit to attending all visits
- •Willing and able to provide informed consent
- •Use of adequate birth control, if of reproductive potential and sexually active
排除标准
- •Widespread AD requiring systemic therapy
- •Use of any of the following treatments within the specified time periods prior to Day 1
- •Topical medications (topical antibiotics, topical corticosteroids, topical antifungals, topical antihistamines, topical retinoids, topical calcipotriene, tacrolimus, pimecrolimus, or other topical drug products for treatment of AD) or bleach bath within 2 weeks prior to Day 1
- •Systemic agents (cyclosporine, systemic corticosteroids [oral and injectable; intranasal and inhaled corticosteroids are allowed if use is kept constant during the study], systemic antibiotics, immunomodulators or immunosuppressive therapies, interferon, cytotoxic drugs [e.g., methotrexate, cyclophosphamide, azathioprine], oral retinoids, systemic antifungals, tacrolimus) for the treatment of AD within 4 weeks prior to Day 1
- •Ultraviolet (UV) therapy or use of a tanning booth/parlor within 6 weeks prior to Day 1
- •Biologic therapies within 12 weeks (or 5 half-lives) prior to Day 1
- •Antihistamines within 5 days prior to Day 1 [stable regimens (consistent use ≥ 14 days before Day 1) of oral H1 antihistamines for non-AD lesion treatment will be allowed]
- •Active or potentially recurrent dermatologic condition other than AD that may confound evaluation
- •Congenital ichthyosis (note that subjects with ichthyosis vulgaris are permitted)
- •Known allergy to any ingredients of the investigational product formulation
- •Significant confounding conditions as assessed by Investigator
- •Any condition that could interfere with any evaluation in the study
- •Pregnancy or breast feeding
- •Any reason which, in the opinion of the Investigator, interferes with the ability of the subject to participate in or complete the trial
研究组 & 干预措施
PR022 topical gel vehicle
Placebo Comparator
Applied twice daily for 28 days
干预措施: PR022 (Drug)
PR022 topical gel, 0.05%
Experimental
Applied twice daily for 28 days
干预措施: PR022 (Drug)
PR022 topical gel, 0.1%
Experimental
Applied twice daily for 28 days
干预措施: PR022 (Drug)
结局指标
主要结局
Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI)
时间窗: 29 days
次要结局
- Percent change from Baseline to Day 29 in body surface area (BSA) affected by AD(29 Days)
- Change from Baseline to Day 29 in SCORing Atopic Dermatitis (SCORAD)(29 Days)
- Percentage of subjects who achieved success in Investigator's Static Global Assessment (ISGA), defined as a score of "Clear" (0) or "Almost Clear" (1) with a minimum 2-grade improvement at Day 29(29 Days)
- Percentage of subjects with EASI-75 (≥ 75% improvement from Baseline) at Day 29(29 Days)
- Percentage of subjects with EASI-50 (≥ 50% improvement from Baseline) at Day 29(29 Days)
- Change from Baseline to Day 29 in 5 dimensions of itch (5-D Itch) scale(29 days)
- Percentage of subjects with an ISGA score of "Clear" (0) or "Almost Clear" (1) at Day 29(29 Days)
- Percent change from Baseline to Day 29 in pruritus Numerical Rating Scale (NRS)(29 Days)
- Change from Baseline to Day 29 in Dermatology Life Quality Index (DLQI)(29 days)
- Frequency counts and percentages of DLQI scores (scored 0 to 3) at Baseline and Day 29, as well as shift in DLQI scores from Baseline to Day 29(29 Days)
研究者
研究点 (1)
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