A Study of Acne Treatment in Children Ages 9 to 11

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907335
• Other study ID #: CA-P-6397
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2009
• Last updated: February 14, 2012
• Start date: February 2009
• Est. completion date: December 2009

Study information

• Verified date: February 2012
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 11 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Retin-A Micro 0.04% facial acne treatment
Retin-A Micro 0.04% facial acne treatment used once daily
• Vehicle control
Color-matched facial gel vehicle control used once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Total Non-inflammatory Lesion Count	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.	Baseline to Week 12	No
Secondary	Change From Baseline in Lesion Counts	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.	Baseline to Week 12	No
Secondary	Measurement of Success 1	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.	Week 12	No
Secondary	Measurement of Success 2	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.	Week 12	No
Secondary	Measurement of Success 3	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.	Week 12	No
Secondary	Global Assessment	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.	Baseline to Week 12	No

External Links

•   FDA's Drug Finder