A Study of Acne Treatment in Children Ages 9 to 11

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

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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