Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide 2.5% in Moderate to Severe Acne in Dark Skin Phototype Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire
研究概览
简要总结
This is a multicenter open-label, prospective study in subjects with dark skin from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American and with moderate to severe acne vulgaris on the face.
All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo Forte/TactuPump Forte) once daily on whole face.
The purpose of this trial is to evaluate subject reported outcomes with the combination of Adapalene 0.3% - BPO 2.5%, Epiduo Forte / TactuPump Forte gel, after 16 weeks of treatment of moderate to severe acne in dark skin phototypes (IV to VI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with clinical diagnosis of moderate to severe facial acne vulgaris, defined by:
- •Investigator's Global Assessment (IGA) score of 3 (Moderate) OR 4 (Severe ); and
- •A minimum of 25-100 inflammatory lesions (papules and pustules); and
- •A minimum of 30-150 non-inflammatory lesions (open and closed comedones) in total (excluding the nose); and
- •No more than two acne nodules (≥ 1 cm),
- •Subject with skin phototype IV to VI on Fitzpatrick skin phototype scale,
- •Subjects from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American,
排除标准
- •Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, acne requiring systemic treatment,
- •Subject with history of lupus, atopic dermatitis, perioral dermatitis, dermatomyositis, rosacea
- •Female subject who is pregnant, lactating or planning a pregnancy during the trial,
- •Subjects having received at least one of the following topical treatments on the treated area: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, dapsone, hydroxyacids, Zinc containing treatments, antiseptics, other anti-inflammatory products or other acne treatments (2 weeks); Retinoids (4 weeks); Cosmetic/aesthetic procedures on the face (1 week); Wax epilation (2 weeks); Photodynamic therapy (6 weeks); Laser therapy, microdermabrasion, deep chemical peel, plastic surgery for acne (3 months).
- •Subjects having received at least one of the following systemic treatments: Corticosteroids, tetracyclines, other antibiotics (except penicillin) (1 month); Oral retinoids/isotretinoin/ anti-androgens / Cyproterone acetate / Chlormadinone acetate (6 months); Spironolactone/ Drospirenone (3 months); Immunomodulators (3 months) and Oral contraceptives/ oral dapsone for acne(1 month).
研究组 & 干预措施
Adapalene / BPO gel
Adapalene 0.3% / BPO 2.5% gel, once daily in the evening
干预措施: Adapalene 0.3% / BPO 2.5% gel (Drug)
结局指标
主要结局
Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire
时间窗: At week 12
% of subjects satisfied to very satisfied with study treatment at week 12
次要结局
未报告次要终点