A Clinical Assessment of the Use of RETIN-A MICRO (Tretinoin Gel) Microsphere, 0.04% in a Pump Dispenser and a 5% Benzoyl Peroxide Wash Used in the Morning Compared to the Use of RETIN-A MICRO 0.04% Pump Nightly and a 5% Benzoyl Peroxide Wash in the Morning For the Treatment of Facial Acne Vulgaris
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 12
- 主要终点
- Change From Baseline in Total Facial Acne Lesion Count
研究概览
简要总结
A study to determine if using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.
详细描述
Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0.04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either both morning treatments (test) or to the morning/evening treatment (active control). Subjects will be assessed at baseline, at week 3, week 6 and again at the end of therapy, week 12 for number and type of individual lesions and safety. At selected sites, photographs will be taken at the same time points. At Week 12 subjects will be assessed for Investigator's Global Assessment of Acne Severity. The investigator will conduct all of the lesion counts, global assessments and safety assessments.
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
- Single (Investigator)
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
- •Males and non-pregnant or non-nursing females, 12 years or older, with facial acne vulgaris;
- •Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules);
- •Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed comedones);
- •Must have at least a rating of grade 3 on the Investigator Global severity scale at baseline
排除标准
- •Known sensitivity to any of the ingredients in the study medication;
- •Any nodulocystic acne lesions;
- •Use of acne devices or systemic therapy with antibiotics within two months prior to start and throughout the duration of the study;
- •Use of systemic therapy with retinoids within four months prior to study start and throughout the duration of the study;
- •Topical use of retinoids within two weeks prior to study start and throughout the duration of the study;
- •Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study;
- •If subject is taking birth control pills, she must be stabilized for at least three months prior to study start;
- •History of evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication;
- •Any significant medical conditions that could confound the interpretation of the study;
- •Excessive facial hair that may interfere with evaluations;
- •No use of tanning booths, sun lamps, etc.
研究组 & 干预措施
Same time of day
5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
干预措施: benzoyl peroxide wash (Drug)
Same time of day
5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
干预措施: Tretinoin gel (Drug)
Different times of day
5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
干预措施: benzoyl peroxide wash (Drug)
Different times of day
5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
干预措施: Tretinoin gel (Drug)
结局指标
主要结局
Change From Baseline in Total Facial Acne Lesion Count
时间窗: Baseline to Week 12
Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.
次要结局
- Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals(Baseline to Week 12)
- Measurement of Success(Baseline to Week 12)