NCT00907335

A Study of Acne Treatment in Children Ages 9 to 11

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 9 Years – 11 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Retin-A Micro 0.04% facial acne treatment	Retin-A Micro 0.04% facial acne treatment used once daily
DRUG	Vehicle control	Color-matched facial gel vehicle control used once daily

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-05-22
• Last updated: 2012-02-15
• Results posted: 2011-03-11

Locations

12 sites across 1 country: United States