- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01139047
Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin
July 28, 2022 updated by: Galderma R&D
Split-Face Tolerability Comparison Between MetroGel® (Metronidazole Gel) 1% vs Finacea® (Azelaic Acid) 15% in Subjects With Healthy Skin
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80915
- Thomas J. Stephens & Associates, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: metronidazole 1% gel
|
Apply topically once daily on one side of the face for three weeks
Other Names:
|
Active Comparator: azelaic acid 15% gel
|
Apply topically twice daily on the opposite side of the face for three weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline to week 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
day 22
|
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
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
June 4, 2010
First Submitted That Met QC Criteria
June 4, 2010
First Posted (Estimate)
June 8, 2010
Study Record Updates
Last Update Posted (Actual)
August 1, 2022
Last Update Submitted That Met QC Criteria
July 28, 2022
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- US10160
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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