Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin

Study Overview
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Brief Summary
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The purpose of this study is to compare the tolerability of MetroGel® 1% to Finacea® 15% in subjects with healthy skin applied according to product labeling for three weeks.

Official Title
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Split-Face Tolerability Comparison Between MetroGel® (Metronidazole Gel) 1% vs Finacea® (Azelaic Acid) 15% in Subjects With Healthy Skin

Conditions
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Skin Manifestations

Intervention / Treatment
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* Drug: metronidazole 1% gel
* Drug: azelaic acid 15% gel


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metronidazole 1% gel<br> | Drug: metronidazole 1% gel<br>* Apply topically once daily on one side of the face for three weeks<br>* Other names: MetroGel® 1% gel;|
| Active Comparator: azelaic acid 15% gel<br> | Drug: azelaic acid 15% gel<br>* Apply topically twice daily on the opposite side of the face for three weeks<br>* Other names: Finacea® 15% Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3 | Number of participants who were a success with regard to worst post-baseline tolerability 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. | baseline to week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. 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 for each assessment. | day 22 | 
| 6 Question Subject Preference Survey at Week 3 | Number of participants per response to each question of the subject preference survey at week 3 | 3 weeks |