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

Condition(s) targeted: Skin Manifestations

Intervention: metronidazole 1% gel (Drug); azelaic acid 15% gel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

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

6 Question Subject Preference Survey at Week 3

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.)

Thomas J. Stephens & Associates, Inc., Colorado Springs, Colorado 80915, United States

Starting date: June 2010
Last updated: September 21, 2012