NCT01149330已完成4 期
Evaluation of Efficacy and Safety of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- Efficacy evaluation
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in the treatment of acne vulgaris. The safety will also be evaluated.
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 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Subjects, aged 12 to 35 years inclusive, with moderate to severe facial acne vulgaris (described scale score of 3 or 4),
- •Subjects with a minimum of 20 and a maximum of 50 Inflammatory Lesions (papules and pustules) on the face, excluding the nose,
- •Subjects with a minimum of 30 and a maximum of 100 Non-Inflammatory Lesions (open comedones and closed comedones) on the face, excluding the nose,
- •Female Subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice a highly effective method of contraception during the study: oral/systemic [injectable, patch...] contraception (must have been on a stable dose for 3 months prior to study entry), Intrauterine Device, strict abstinence, condoms, diaphragms, sponge, spermicides or partner had a vasectomy,
- •Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, secondary infertility and sterility are not required to have a UPT at the beginning of the study,
- •Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study. Subjects under the majority must sign an assent-to-participate form to participate in the study and they must have one parent or guardian read and sign the Informed Consent form prior to any study related procedure,
- •Subjects willing and capable of cooperating to the extend and degree required by the protocol.
排除标准
- •Subjects who have participated in another investigational drug or device research study within 30 days of enrollment,
- •Female Subjects who are pregnant, nursing or planning a pregnancy during the study,
- •Subjects with more than 1 nodule or cyst on the face
- •Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
- •Subjects with known or suspected allergy to one of the investigational products (see package insert and/or investigator brochure),
- •Subjects who have pathological conditions photosensitive porphyria, SLE, LED, solar polymorphous eruption, actinic prurigo, solar urticaria, etc.
- •Subjects with a beard or other facial hair that might interfere with study assessments,
- •Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...)
- •Female subjects with a history of hormonal changes.
- •Subjects with skin condition or disease requiring topical or systemic therapy, which interferes with the investigational product or that may directly affect the evaluation criteria:
- •Topical treatment for acne in the past two weeks.
- •Anti-inflammatory topic in the last two weeks.
- •Use of topical corticosteroids on the face in the last four weeks.
- •Anti-inflammatory systemic (hormonal or not) in the last four weeks.
- •Use of systemic corticosteroids in the last four weeks.
- •Systemic antibiotics in the last four weeks (excluding penicillins).
- •Systemic retinoids in the last six months.
- •Other systemic anti-acne the last four weeks.
- •Anticonceptional oral used exclusively for the control of acne in the past six months.
- •Cosmetic procedures such as facials, peels, exfoliation, extraction of comedones, application of LED, laser or pulsed light in the last two weeks.
- •Cosmetic procedures such as PDT in the last four weeks.
研究组 & 干预措施
Adapalene-BPO Gel
Experimental
干预措施: Adapalene-BPO Gel (Drug)
结局指标
主要结局
Efficacy evaluation
时间窗: Week 12
Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 12.
次要结局
- Secondary efficacy evaluation(Week 12)
- Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 2. Secondary efficacy evaluation(Week 4)
- Safety evaluation(Week 12)
研究者
研究点 (6)
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