Status:
COMPLETED
A Study of Acne Treatment in Children Ages 9 to 11
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
9-11 years
Phase:
PHASE2
Brief 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.
Detailed Description
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 screeni...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00907335
Start Date
February 1 2009
End Date
December 1 2009
Last Update
February 15 2012
Active Locations (12)
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1
Encino Research Center
Encino, California, United States, 91436
2
Children's Hospital and Health Center
San Diego, California, United States, 92123
3
Department of Dermatology, University of Miami
Miami, Florida, United States, 33136
4
Department of Dermatology, Northwestern University
Chicago, Illinois, United States, 60611