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Phase 2 Completed N=110 Randomized Double-blind Treatment

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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