A Study of Acne Treatment in Children Ages 9 to 11

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: Retin-A Micro 0.04% facial acne treatment; Drug: Vehicle control	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	110 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	February 2009
Actual Primary Completion Date :	December 2009
Actual Study Completion Date :	December 2009

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Change From Baseline in Total Non-inflammatory Lesion Count [ Time Frame: 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 :

1. Change From Baseline in Lesion Counts [ Time Frame: 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.
2. Measurement of Success 1 [ Time Frame: 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.
3. Measurement of Success 2 [ Time Frame: 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.
4. Measurement of Success 3 [ Time Frame: 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.
5. Global Assessment [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	9 Years to 11 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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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

Sponsors and Collaborators

Valeant Pharmaceuticals International, Inc.

Investigators

Study Director:	Ana Rossi, MD	Johnson & Johnson Consumer and Personal Products Worldwide

More Information

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Additional Information:

FDA's Drug Finder 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Eichenfield LF, Hebert AA, Schachner L, Paller AS, Rossi AB, Lucky AW. Tretinoin microsphere gel 0.04% pump for treating acne vulgaris in preadolescents: a randomized, controlled study. Pediatr Dermatol. 2012 Sep-Oct;29(5):598-604. doi: 10.1111/j.1525-1470.2012.01811.x. Epub 2012 Jun 19.

Responsible Party:	Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:	NCT00907335 History of Changes
Other Study ID Numbers:	CA-P-6397
First Posted:	May 22, 2009
Results First Posted:	March 11, 2011
Last Update Posted:	February 15, 2012
Last Verified:	February 2012

Keywords provided by Valeant Pharmaceuticals International, Inc.:

acne; irritation; objective sensory methods

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Benzoyl Peroxide	Tretinoin; Dermatologic Agents; Antineoplastic Agents; Keratolytic Agents