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

Galderma

Status and phase

Completed

Phase 4

Conditions

Skin Manifestations

Treatments

Drug: azelaic acid 15% gel

Drug: metronidazole 1% gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01139008

US10159

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.)