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

NCT01139008 | Completed Phase 4 Results

• 1 other identifier: US10159
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Manifestations

Outcome Measures

Primary Outcomes (1)

• 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

  Number of participants who were a success with regard to worst post-baseline tolerability assessment 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.

  baseline to week 3

Secondary Outcomes (2)

• 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.

  Day 22

• 6 Question Subject Preference Survey at Week 3

  week 3

Study Arms (2)

metronidazole 1% gel

ACTIVE COMPARATOR

Drug: metronidazole 1% gel

azelaic acid 15% gel

ACTIVE COMPARATOR

Drug: azelaic acid 15% gel

Interventions

metronidazole 1% gel DRUG

Apply topically on one side of the face once daily for three weeks

Also known as: MetroGel® 1%

metronidazole 1% gel

azelaic acid 15% gel DRUG

Apply topically on the opposite side of the face twice daily for three weeks

Also known as: Finacea® 15% Gel

azelaic acid 15% gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female adults (ages 18 years or older)
• Subjects with healthy skin as determined by the clinical grader

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Thomas J. Stephens and Associates, Inc.

Carrollton, Texas, 75006, United States

Location

MeSH Terms

Conditions

Skin Manifestations

Interventions

Metronidazole; Gels; azelaic acid

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Ronald W. Gottschalk, MD / Medical Director
• Organization: Galderma Laboratories, L.P.

ron.gottschalk@galderma.com

817-961-5358

Study Officials

• Ronald W Gottschalk, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 8, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 1, 2022
• Results First Posted: July 26, 2011

Record last verified: 2012-09

Locations

US (1)