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

Purpose

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.

Condition	Intervention	Phase
Skin Manifestations	Drug: metronidazole 1% gel Drug: azelaic acid 15% gel	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Split-Face Tolerability Comparison Between MetroGel® (Metronidazole Gel) 1% vs Finacea® (Azelaic Acid) 15% in Subjects With Healthy Skin

Resource links provided by NLM:

Drug Information available for: Azelaic acid Metronidazole Metronidazole benzoate Metronidazole hydrochloride

U.S. FDA Resources

Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:

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 [ Time Frame: baseline to week 3 ] [ Designated as safety issue: Yes ]
Number of participants who were a success with regard to worst post-baseline tolerability 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 Outcome 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 ] [ Designated as safety issue: Yes ]
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: 3 weeks ] [ Designated as safety issue: No ]
Number of participants per response to each question of the subject preference survey at week 3

Enrollment:	77
Study Start Date:	June 2010
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: metronidazole 1% gel	Drug: metronidazole 1% gel Apply topically once daily on one side of the face for three weeks Other Name: MetroGel® 1% gel
Active Comparator: azelaic acid 15% gel	Drug: azelaic acid 15% gel Apply topically twice daily on the opposite side of the face for three weeks Other Name: Finacea® 15% Gel

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139047

Locations

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

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, L.P.

More Information

No publications provided

Responsible Party:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT01139047 History of Changes
Other Study ID Numbers:	US10160
Study First Received:	June 4, 2010
Results First Received:	June 28, 2011
Last Updated:	September 21, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Skin Manifestations
Signs and Symptoms
Metronidazole
Azelaic acid
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents
Dermatologic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 22, 2013