A Study of Acne Treatment in Children Ages 9 to 11

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Benzoyl Peroxide; Tretinoin

Criteria

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