A Study of Acne Treatment in Children Ages 9 to 11

Completed · Phase 2 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT00907335

Run by

Bausch Health Americas, Inc.

People needed

110

Starts

2009-02-01

Expected to finish

2009-12-01

Last updated by the study team

2012-02-15

Who can join

Age: 9 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Encino Research Center — Encino, California, United States
• Children's Hospital and Health Center — San Diego, California, United States
• Department of Dermatology, University of Miami — Miami, Florida, United States
• Department of Dermatology, Northwestern University — Chicago, Illinois, United States
• Dermatology Associates — Louisville, Kentucky, United States
• UMDNJ-RWJ Medical School — Somerset, New Jersey, United States
• SUNY Downstate Medical Center Department of Dermatology — Brooklyn, New York, United States
• Dermatology Research Associates — Cincinnatti, Ohio, United States
• Skin Study Center — Broomall, Pennsylvania, United States
• Yardley Dermatology Associates — Yardley, Pennsylvania, United States
• Omega Medical Research — Warwick, Rhode Island, United States
• University of Texas Medical School at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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