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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01139047
Other study ID # US10160
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.


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Study Design


Related Conditions & MeSH terms


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
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