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| Sponsor: | Johnson & Johnson Consumer & Personal Products Worldwide |
|---|---|
| Information provided by (Responsible Party): | Johnson & Johnson Consumer & Personal Products Worldwide |
| ClinicalTrials.gov Identifier: | NCT00907335 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: Retin-A Micro 0.04% facial acne treatment Drug: Vehicle control |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 110 |
| Study Start Date: | February 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Retin-A Micro
Retin-A Micro 0.04% facial acne treatment used once daily
|
Drug: Retin-A Micro 0.04% facial acne treatment
Retin-A Micro 0.04% facial acne treatment used once daily
Other Name: facial acne treatment
|
|
Placebo Comparator: Vehicle Control
Color matched facial gel vehicle control used once daily
|
Drug: Vehicle control
Color-matched facial gel vehicle control used once daily
Other Name: placebo
|
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| Ages Eligible for Study: | 9 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Encino Research Center | |
| Encino, California, United States, 91436 | |
| Children's Hospital and Health Center | |
| San Diego, California, United States, 92123 | |
| United States, Florida | |
| Department of Dermatology, University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Illinois | |
| Department of Dermatology, Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Kentucky | |
| Dermatology Associates | |
| Louisville, Kentucky, United States, 40202 | |
| United States, New Jersey | |
| UMDNJ-RWJ Medical School | |
| Somerset, New Jersey, United States, 08873 | |
| United States, New York | |
| SUNY Downstate Medical Center Department of Dermatology | |
| Brooklyn, New York, United States, 11203 | |
| United States, Ohio | |
| Dermatology Research Associates | |
| Cincinnatti, Ohio, United States, 45230 | |
| United States, Pennsylvania | |
| Skin Study Center | |
| Broomall, Pennsylvania, United States, 19008 | |
| Yardley Dermatology Associates | |
| Yardley, Pennsylvania, United States, 19067 | |
| United States, Rhode Island | |
| Omega Medical Research | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, Texas | |
| University of Texas Medical School at Houston | |
| Houston, Texas, United States, 77030 | |
| Study Director: | Ana Rossi, MD | Johnson & Johnson Consumer & Personal Products Worldwide |
More Information
| Responsible Party: | Johnson & Johnson Consumer & Personal Products Worldwide |
| ClinicalTrials.gov Identifier: | NCT00907335 History of Changes |
| Other Study ID Numbers: | CA-P-6397 |
| Study First Received: | May 20, 2009 |
| Results First Received: | November 30, 2010 |
| Last Updated: | October 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
acne irritation objective sensory methods |
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Benzoyl Peroxide |
Tretinoin Dermatologic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Keratolytic Agents |