Phase 4
Completed N=73
Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel
Source: ClinicalTrials.gov NCT01522456 ↗Enrolled (actual)
73
Serious AEs
0.5%
Results posted
Aug 2015
Primary outcomePrimary: Worst Postbaseline Tolerability (Erythema) — 25; 28; 27; 24 participants
Summary
To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3 weeks in terms of local tolerability parameters (erythema, dryness, scaling, stinging/burning) and preference.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Worst Postbaseline Tolerability (Erythema) |
25; 28; 27; 24; 19; 19 | — |
| PRIMARY Worst Postbaseline Tolerability (Scaling) |
25; 18; 34; 43; 14; 12 | — |
| PRIMARY Worst Postbaseline Tolerability (Dryness) |
34; 28; 35; 41; 4; 4 | — |
| PRIMARY Worst Postbaseline Tolerability (Stinging/Burning) |
51; 57; 18; 14; 3; 2 | — |
| SECONDARY Tolerability at Day 22 (Erythema) |
36; 38; 33; 28; 0; 3 | — |
| SECONDARY Tolerability at Day 22 (Dryness) |
44; 40; 25; 29; 0; 0 | — |
| SECONDARY Tolerability at Day 22 (Scaling) |
54; 48; 12; 20; 3; 1 | — |
| SECONDARY Tolerability at Day 22 (Stinging/Burning) |
69; 69; 0; 0; 0; 0 | — |
| SECONDARY Cumulative Tolerability (Erythema) |
26; 26; 56; 52; 86; 79 | — |
| SECONDARY Cumulative Tolerability (Scaling) |
1; 0; 1; 0; 5; 3 | — |
| SECONDARY Cumulative Tolerability (Dryness) |
2; 1; 3; 2; 6; 2 | — |
| SECONDARY Cumulative Tolerability (Stinging/Burning) |
0; 0; 0; 1; 1; 2 | — |
| SECONDARY Cumulative Tolerability (Combined) |
29; 27; 60; 55; 98; 86 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects of any race
- Subjects 18 years or older
- Subjects with acne vulgaris
Exclusion Criteria
- Subjects with an allergy to a component of the study drugs (refer to the package inserts for Epiduo Gel and Retin-A Micro 0.1%)
- Subjects with a washout period for topical treatment (less than 1 week for corticosteroids or 4 weeks for retinoids)
- Subjects with a washout period for systemic treatment (less than 1 week for medications that may have increased photosensitivity or 4 weeks for corticosteroids or 24 weeks for oral retinoids)
- Subjects with a sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the treatment area
- Subjects with planned unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc)
Data sourced from ClinicalTrials.gov (NCT01522456). 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.