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

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ClinicalTrials.gov Identifier: NCT01139047
Recruitment Status : Completed
First Posted : June 8, 2010
Results First Posted : July 26, 2011
Last Update Posted : August 1, 2022
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Skin Manifestations Drug: metronidazole 1% gel Drug: azelaic acid 15% gel Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : June 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.

  2. 6 Question Subject Preference Survey at Week 3 [ Time Frame: 3 weeks ]
    Number of participants per response to each question of the subject preference survey at week 3


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139047


Locations
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United States, Colorado
Thomas J. Stephens & Associates, Inc.
Colorado Springs, Colorado, United States, 80915
Sponsors and Collaborators
Galderma R&D
Investigators
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Study Director: Ronald W Gottschalk, MD Galderma R&D
More Information
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01139047    
Other Study ID Numbers: US10160
First Posted: June 8, 2010    Key Record Dates
Results First Posted: July 26, 2011
Last Update Posted: August 1, 2022
Last Verified: September 2012
Additional relevant MeSH terms:
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Skin Manifestations
Metronidazole
Azelaic acid
Anti-Infective Agents
Anti-Bacterial Agents
 Antiprotozoal Agents
Antiparasitic Agents
Antineoplastic Agents
Dermatologic Agents