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A Study of Acne Treatment in Children Ages 9 to 11

Information source: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: Retin-A Micro 0.04% facial acne treatment (Drug); Vehicle control (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Valeant Pharmaceuticals International, Inc.

Official(s) and/or principal investigator(s):
Ana Rossi, MD, Study Director, Affiliation: Johnson & Johnson Consumer and Personal Products Worldwide


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Total Non-inflammatory Lesion Count

Secondary outcome:

Change From Baseline in Lesion Counts

Measurement of Success 1

Measurement of Success 2

Measurement of Success 3

Global Assessment

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 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.


Minimum age: 9 Years. Maximum age: 11 Years. Gender(s): Both.


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


- 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

Locations and Contacts

Encino Research Center, Encino, California 91436, United States

Children's Hospital and Health Center, San Diego, California 92123, United States

Department of Dermatology, University of Miami, Miami, Florida 33136, United States

Department of Dermatology, Northwestern University, Chicago, Illinois 60611, United States

Dermatology Associates, Louisville, Kentucky 40202, United States

UMDNJ-RWJ Medical School, Somerset, New Jersey 08873, United States

SUNY Downstate Medical Center Department of Dermatology, Brooklyn, New York 11203, United States

Dermatology Research Associates, Cincinnatti, Ohio 45230, United States

Skin Study Center, Broomall, Pennsylvania 19008, United States

Yardley Dermatology Associates, Yardley, Pennsylvania 19067, United States

Omega Medical Research, Warwick, Rhode Island 02886, United States

University of Texas Medical School at Houston, Houston, Texas 77030, United States

Additional Information

FDA's Drug Finder

Starting date: February 2009
Last updated: February 14, 2012

Page last updated: August 23, 2015

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