A Study of Acne Treatment in Children Ages 9 to 11

NCT ID: NCT00907335

Last Updated: 2012-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-12-31

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 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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Retin-A Micro

Retin-A Micro 0.04% facial acne treatment used once daily

Group Type: EXPERIMENTAL

Retin-A Micro 0.04% facial acne treatment

Intervention Type: DRUG

Retin-A Micro 0.04% facial acne treatment used once daily

Vehicle Control

Color matched facial gel vehicle control used once daily

Group Type: PLACEBO_COMPARATOR

Vehicle control

Intervention Type: DRUG

Color-matched facial gel vehicle control used once daily

Interventions

Retin-A Micro 0.04% facial acne treatment

Retin-A Micro 0.04% facial acne treatment used once daily

Intervention Type: DRUG

Vehicle control

Color-matched facial gel vehicle control used once daily

Intervention Type: DRUG

Other Intervention Names

facial acne treatment; placebo

Eligibility 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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Rossi, MD

Role: STUDY_DIRECTOR

Johnson & Johnson Consumer and Personal Products Worldwide

Locations

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

Countries

United States

References

Eichenfield LF, Hebert AA, Schachner L, Paller AS, Rossi AB, Lucky AW. Tretinoin microsphere gel 0.04% pump for treating acne vulgaris in preadolescents: a randomized, controlled study. Pediatr Dermatol. 2012 Sep-Oct;29(5):598-604. doi: 10.1111/j.1525-1470.2012.01811.x. Epub 2012 Jun 19.

Reference Type: DERIVED

PMID: 22712470 (View on PubMed)

Related Links

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

FDA's Drug Finder

Other Identifiers

CA-P-6397

Identifier Type: -

Identifier Source: org_study_id