Phase 3
Completed N=61
A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash
Source: ClinicalTrials.gov NCT00891982 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcomePrimary: Local Tolerability - Skin Dryness — 28; 26; 2; 4 participants
Summary
The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Tolerability - Skin Dryness |
19; 19; 7; 11; 2; 1 | — |
| PRIMARY Local Tolerability - Skin Scaling |
20; 25; 6; 5; 2; 1 | — |
| PRIMARY Local Tolerability - Erythema (Redness) |
15; 16; 5; 9; 4; 4 | — |
| SECONDARY Subject Assessment of Burning/Stinging |
23; 14; 4; 15; 0; 1 | — |
| SECONDARY Subject Assessment of Itching |
18; 21; 9; 8; 0; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with mild to moderate facial acne vulgaris, with no history of known or suspected hypersensitivity or previous allergic reaction to any of the ingredients of the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable of understanding and willing to provide signed and dated written voluntary informed consent and able to complete the study and to comply with study instructions.
- Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
Exclusion Criteria
- Use of topical antibiotics on the face within the past 2 weeks or use of systemic antibiotics within the past 4 weeks.
Data sourced from ClinicalTrials.gov (NCT00891982). 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.