Overview

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

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Galderma Laboratories, L.P.
Treatments:
Azelaic acid
Metronidazole
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.)