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

Phase 4

Completed

• Conditions: Skin Manifestations
• Interventions: Drug: metronidazole 1% gel; Drug: azelaic acid 15% gel

• Registration Number: NCT01139047
• Lead Sponsor: Galderma R&D

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-08
• Results First Submitted: 2011-06-28
• Results First Submitted QC: 2011-06-28
• Results First Posted: 2011-07-26
• Status Verified: 2012-09
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metronidazole 1% gel	metronidazole 1% gel	-
azelaic acid 15% gel	azelaic acid 15% gel	-

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
6 Question Subject Preference Survey at Week 3	3 weeks	Number of participants per response to each question of the subject preference survey at week 3
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	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.

Trial Locations

Locations (1)

Thomas J. Stephens & Associates, Inc.; 🇺🇸 Colorado Springs, Colorado, United States