A Study of Acne Treatment in Children Ages 9 to 11

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Retin-A Micro 0.04% facial acne treatment
* Drug: Vehicle control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retin-A Micro<br>Retin-A Micro 0.04% facial acne treatment used once daily | Drug: Retin-A Micro 0.04% facial acne treatment<br>* Retin-A Micro 0.04% facial acne treatment used once daily<br>* Other names: facial acne treatment;|
| Placebo Comparator: Vehicle Control<br>Color matched facial gel vehicle control used once daily | Drug: Vehicle control<br>* Color-matched facial gel vehicle control used once daily<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne, irritation, objective sensory methods