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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Skin Manifestations | Drug: metronidazole 1% gel Drug: azelaic acid 15% gel | Phase 4 |
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 |

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 |
- 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.
- 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.
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.)

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
United States, Colorado | |
Thomas J. Stephens & Associates, Inc. | |
Colorado Springs, Colorado, United States, 80915 |
Study Director: | Ronald W Gottschalk, MD | Galderma R&D |
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 |
Skin Manifestations Metronidazole Azelaic acid Anti-Infective Agents Anti-Bacterial Agents |
Antiprotozoal Agents Antiparasitic Agents Antineoplastic Agents Dermatologic Agents |