Randomized, Double Blind, Placebo Controlled, Parallel Group Design, Three Arm, Multicentric Study to Evaluate the Efficacy and Safety of Topical Adapalene Gel, 0.1 % in Healthy Males and Nonpregnant Female Subjects With Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Mean percent change from baseline in the non-inflammatory lesion count.
研究概览
简要总结
To evaluate the therapeutic equivalence of topical Adapalene Gel, 0.1 % and Differin®(Adapalene) Gel, 0.1 % in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.
详细描述
Bio-Equivalence study with a clinical endpoint in the treatment of acne vulgaris comparing adapalene cream, 0.1% test product versus the reference listed drug (RLD) and placebo (vehicle) control, each administered as one application once a day in the evening for 12 weeks
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
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or nonpregnant, nonlactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
- •On the face, ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts)
- •Investigator's Global Assessment (IGA) of acne severity Grade 2, 3, or 4
- •Willing to refrain from use of all other topical acne medications or antibiotics during the 12-week treatment period
- •If female of childbearing potential, willing to use an acceptable form of birth control during the study
排除标准
- •Pregnant, breast feeding or planning a pregnancy
- •Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis)
- •Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris
- •History of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients
- •Use within 6 months prior to baseline or during the study of oral retinoids (e.g., Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed)
- •Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study
- •Use on the face within 1 month prior to baseline or during the study of 1) cryo destruction or chemo destruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy
- •Use within 1 month prior to baseline or during the study of 1) systemic steroids, 2) systemic antibiotics, 3) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 4) systemic anti-inflammatory agents
- •Use within 2 weeks prior to baseline or during the study of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, or 5) topical antibiotics
研究组 & 干预措施
Test Group
Adapalene Gel, 0.1%, applied as thin film once daily for 12 weeks
干预措施: Adapalene 0.1% Gel (Drug)
Reference Group
Differin® (Adapalene) Gel, 0.1%, applied as thin film once daily for 12 weeks
干预措施: Differin 0.1% Topical Gel (Drug)
Placebo Group
Placebo Gel, 0.1%, applied as thin film once daily for 12 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Mean percent change from baseline in the non-inflammatory lesion count.
时间窗: 12 weeks
Mean percent change compared to baseline non-inflammatory lesion count (open and closed comedones) at Day 84 in per protocol population.
Mean percent change from baseline in the inflammatory lesion count.
时间窗: 12 weeks
Mean percent change compared to baseline inflammatory lesion count (papules and pustules) at Day 84 in per protocol population.
次要结局
- Proportion of subjects with a clinical response as success or failure(12 weeks)
- Change in lesion count(12 weeks)