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

Skin Manifestations Clinical Trial

Official title:

Split-Face Tolerability Comparison Between MetroGel® (Metronidazole Gel) 1% vs Finacea® (Azelaic Acid) 15% in Subjects With Healthy Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139047
• Other study ID #: US10160
• Status: Completed
• Phase: Phase 4
• Start date: June 2010
• Est. completion date: June 2010

Study information

• Verified date: September 2012
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Skin Manifestations

Intervention

Drug:
• metronidazole 1% gel
Apply topically once daily on one side of the face for three weeks
• azelaic acid 15% gel
Apply topically twice daily on the opposite side of the face for three weeks

Locations

Country	Name	City	State
United States	Thomas J. Stephens & Associates, Inc.	Colorado Springs	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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
Secondary	6 Question Subject Preference Survey at Week 3	Number of participants per response to each question of the subject preference survey at week 3	3 weeks