A Study of Acne Treatment in Children Ages 9 to 11

Phase 2

Completed

Conditions: Acne Vulgaris

Interventions: Drug: Retin-A Micro 0.04% facial acne treatment
Drug: Vehicle control

Registration Number: NCT00907335

Lead Sponsor: Bausch Health Americas, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 110

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retin-A Micro	Retin-A Micro 0.04% facial acne treatment	Retin-A Micro 0.04% facial acne treatment used once daily
Vehicle Control	Vehicle control	Color matched facial gel vehicle control used once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Total Non-inflammatory Lesion Count	Baseline to Week 12	Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Lesion Counts	Baseline to Week 12	Change from baseline in Lesion Count by the following categories: Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. Inflammatory lesions were the sum of papules and pustules. Total lesions were the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. For each lesion type, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.
Measurement of Success 1	Week 12	Participants achieving success according to the Investigator Global Assessment (IGA #1) - (Pediatric Acne Scale) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), severe (4), and very severe (5). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.
Measurement of Success 2	Week 12	Participants achieving success according to dichotomized Investigator Global Assessment (IGA) scores - Food and Drug Administration Score (IGA#2) The IGA #2 (static 5 point scale recommended in the FDA acne guidelines) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.
Measurement of Success 3	Week 12	Participants achieving success according to Investigator Global Assessment (IGA#3) scores. At Week 12, the IGA #3 rated the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. The number of participants for which treatment was considered successful was based on the IGA #3 success criteria defined as achievement of "Excellent" or "Good" scores.
Global Assessment	Baseline to Week 12	Participants showing improvement from baseline in the Investigator's Global Assessment, in the Intent to Treat population using the Last Available Measurement and imputation technique of Last Observation Carried Forward, rating the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse.

Trial Locations

Locations (12): Dermatology Research Associates
🇺🇸
Cincinnatti, Ohio, United States
Department of Dermatology, Northwestern University
🇺🇸
Chicago, Illinois, United States
Encino Research Center
🇺🇸
Encino, California, United States
Children's Hospital and Health Center
🇺🇸
San Diego, California, United States
UMDNJ-RWJ Medical School
🇺🇸
Somerset, New Jersey, United States
Department of Dermatology, University of Miami
🇺🇸
Miami, Florida, United States
Yardley Dermatology Associates
🇺🇸
Yardley, Pennsylvania, United States
SUNY Downstate Medical Center Department of Dermatology
🇺🇸
Brooklyn, New York, United States
Skin Study Center
🇺🇸
Broomall, Pennsylvania, United States
Dermatology Associates
🇺🇸
Louisville, Kentucky, United States
University of Texas Medical School at Houston
🇺🇸
Houston, Texas, United States
Omega Medical Research
🇺🇸
Warwick, Rhode Island, United States