A Study of Acne Treatment in Children Ages 9 to 11

Bausch Health

Status and phase

Completed

Phase 2

Conditions

Acne Vulgaris

Treatments

Drug: Retin-A Micro 0.04% facial acne treatment

Drug: Vehicle control

Study type

Interventional

Funder types

Industry

Identifiers

NCT00907335

CA-P-6397

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

All

Ages

9 to 11 years old

Volunteers

No Healthy Volunteers

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