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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT01139008
First received: June 4, 2010
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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.


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% Versus Finacea® (Azelaic Acid) Gel 15% in Subjects With Healthy Skin

Resource links provided by NLM:


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 Assessment 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 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.


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: week 3 ] [ Designated as safety issue: No ]
    Number of participants per response to each question of the Subject Preference Survey at week 3


Enrollment: 80
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 on one side of the face once daily for three weeks
Other Name: MetroGel® 1%
Active Comparator: azelaic acid 15% gel Drug: azelaic acid 15% gel
Apply topically on the opposite side of the face twice daily 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: NCT01139008

Locations
United States, Texas
Thomas J. Stephens and Associates, Inc.
Carrollton, Texas, United States, 75006
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: NCT01139008     History of Changes
Other Study ID Numbers: US10159
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 April 17, 2014