A Multi-Center, Double Blind, Vehicle Controlled, Study of Retin-A Micro 0.04% in the Treatment of Pediatric Acne Vulgaris in Children, Ages 9 to 11 Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 12
- 主要终点
- Change From Baseline in Total Non-inflammatory Lesion Count
研究概览
简要总结
A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9 to 11 is safe and efficacious.
详细描述
Approximately 100 female and male subjects, aged from 9 to 11 years of age, will be enrolled in this randomized, double blind, multi-center study.
Following satisfaction of entry criteria and screening procedures, subjects will receive either RETIN-A MICRO 0.04% or a color matched gel vehicle for once daily use during the 12-week treatment period. Subjects will be monitored for safety throughout the study and for signs and symptoms of local irritation at baseline, and at weeks 2, 4, 6, 8, 10 and again at study completion, week 12.
Efficacy will be assessed by facial lesion counts and by utilizing scales for Investigator's Global Evaluation of Acne Severity (IGA #1 and IGA #2) and Investigator's Global Assessment of Improvement (IGA #3). All efficacy parameters with the exception of IGA #3 will be measured at baseline and weeks 2, 4, 6, 8, 10 and 12. The Investigator's Global Assessment of Improvement (IGA #3) will be done at Week 12 only. At selected sites, photographs will be taken at Baseline and weeks 2, 4, 8 and 12.
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
- 9 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant, non-nursing females, 9 to 11 years, with facial pediatric acne vulgaris
- •Minimum of 20 non-inflammatory lesions (open and closed comedones)
- •Minimum of 30 total facial lesions (sum of inflammatory and non-inflammatory)
- •Must have at least a rating of grade 3 on the Investigator Global Assessment Scale for acne severity (IGA #1) 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 topical 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
- •Use of an experimental drug or device within 60 days prior to study start;
- •Use of hormonal therapy within 3 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
- •History of/or current facial skin cancer
- •Inability to refrain from use of all facial products other than those supplied by the study, while participating in the study
- •No use of tanning booths, sun lamps, etc.
- •Subject is a family member of the employee or the investigator
研究组 & 干预措施
Retin-A Micro
Retin-A Micro 0.04% facial acne treatment used once daily
干预措施: Retin-A Micro 0.04% facial acne treatment (Drug)
Vehicle Control
Color matched facial gel vehicle control used once daily
干预措施: Vehicle control (Drug)
结局指标
主要结局
Change From Baseline in Total Non-inflammatory Lesion Count
时间窗: Baseline to Week 12
Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.
次要结局
- Change From Baseline in Lesion Counts(Baseline to Week 12)
- Measurement of Success 1(Week 12)
- Measurement of Success 2(Week 12)
- Measurement of Success 3(Week 12)
- Global Assessment(Baseline to Week 12)