Phase 4
Completed N=80
Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin
Skin Manifestations
Source: ClinicalTrials.gov NCT01139008 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcomePrimary: Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3 — 14; 11; 79; 78 participants
Summary
The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1% to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product labeling for three weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3 |
14; 11; 79; 78; 71; 70 | — |
| SECONDARY Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22. |
34; 29; 74; 73; 73; 73 | — |
| SECONDARY 6 Question Subject Preference Survey at Week 3 |
16; 20; 31; 11; 2; 16 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male and female adults (ages 18 years or older)
- Subjects with healthy skin as determined by the clinical grader
Exclusion Criteria
- Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions
- Subjects with known allergy to one of the components of the study drugs (refer to the package inserts for MetroGel® 1% and Finacea® Gel 15%)
- Subjects who have participated in another investigational drug or device research study within 30 days of enrollment
- Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids
- Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids
- Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the area to be treated
- Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
Data sourced from ClinicalTrials.gov (NCT01139008). 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.