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

Information source: Galderma Laboratories, L.P.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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.

Summary

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.

Clinical Details

Official title: Split-Face Tolerability Comparison Between MetroGel (Metronidazole Gel) 1% Versus Finacea (Azelaic Acid) Gel 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 Assessment 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

Eligibility

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.)

Locations and Contacts

Thomas J. Stephens and Associates, Inc., Carrollton, Texas 75006, United States
Additional Information

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

Page last updated: August 23, 2015

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