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

Overview

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.

Full Title of Study: “Split-Face Tolerability Comparison Between MetroGel® (Metronidazole Gel) 1% Versus Finacea® (Azelaic Acid) Gel 15% in Subjects With Healthy Skin”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 2010

Interventions

  • Drug: metronidazole 1% gel
    • Apply topically on one side of the face once daily for three weeks
  • Drug: azelaic acid 15% gel
    • Apply topically on the opposite side of the face twice daily for three weeks

Arms, Groups and Cohorts

  • Active Comparator: metronidazole 1% gel
  • Active Comparator: azelaic acid 15% gel

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
    • Time Frame: 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.
  • 6 Question Subject Preference Survey at Week 3
    • Time Frame: week 3
    • Number of participants per response to each question of the Subject Preference Survey at week 3

Participating in This Clinical Trial

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.)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Galderma R&D
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ronald W Gottschalk, MD, Study Director, Galderma R&D

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