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