Phase 4
Completed N=247
A Study of Different Use Regimens Using Two Acne Treatments
Source: ClinicalTrials.gov NCT00907257 ↗Enrolled (actual)
247
Serious AEs
1.2%
Results posted
Jan 2011
Primary outcomePrimary: Change From Baseline in Total Facial Acne Lesion Count — 39.74; 40.02 Lesions
Summary
A study to determine if using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Facial Acne Lesion Count |
39.74; 40.02 | — |
| SECONDARY Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals |
14.6; 14.2; 23.2; 23.7; 37.4; 38.1 | — |
| SECONDARY Measurement of Success |
26; 25; 51; 54 | — |
Eligibility Criteria
Inclusion Criteria
- Males and non-pregnant or non-nursing females, 12 years or older, with facial acne vulgaris;
- Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules);
- Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed comedones);
- Must have at least a rating of grade 3 on the Investigator Global severity scale 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 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;
- If subject is taking birth control pills, she must be stabilized for at least three 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;
- Excessive facial hair that may interfere with evaluations;
- No use of tanning booths, sun lamps, etc.
Data sourced from ClinicalTrials.gov (NCT00907257). 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.