Phase 2
Completed N=110
A Study of Acne Treatment in Children Ages 9 to 11
Source: ClinicalTrials.gov NCT00907335 ↗Enrolled (actual)
110
Serious AEs
0.9%
Results posted
Mar 2011
Primary outcomePrimary: Change From Baseline in Total Non-inflammatory Lesion Count — -19.9; -9.7 Lesions
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Non-inflammatory Lesion Count |
-19.9; -9.7 | — |
| SECONDARY Change From Baseline in Lesion Counts |
-19.85; -9.67; -0.63; 0.54; -21.87; -10.88 | — |
| SECONDARY Measurement of Success 1 |
11; 11; 15; 12 | — |
| SECONDARY Measurement of Success 2 |
10; 10; 8; 8 | — |
| SECONDARY Measurement of Success 3 |
31; 27; 16; 27 | — |
| SECONDARY Global Assessment |
12; 7; 19; 20; 11; 9 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00907335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.