Split-Face Tolerability Comparison Between MetroGel® (Metronidazole Gel) 1% Versus Finacea® (Azelaic Acid) Gel 15% in Subjects With Healthy Skin
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.)
Arms & Interventions
metronidazole 1% gel
Intervention: metronidazole 1% gel (Drug)
azelaic acid 15% gel
Intervention: azelaic acid 15% gel (Drug)
Outcomes
Primary Outcomes
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
Time Frame: baseline to week 3
Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0.
Secondary Outcomes
- 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.(Day 22)
- 6 Question Subject Preference Survey at Week 3(week 3)