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NCT00668655 Clinical Trial

An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%

Rosacea Clinical Trial

Official title:
An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00668655
Other study ID # US10086
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2008
Est. completion date March 2008

Study information
Verified date September 2012
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine the cosmetic appearance of metronidazole gel (MetroGel®) 1% with commonly marketed facial foundations.

Description:

Evaluate the relationship between treatment with MetroGel® 1% and cosmetic performance with the Subjects' usual cosmetic products. It is expected that the female subjects will be able to use their routine cosmetics after application without affecting the cosmetic product's performance or causing side effects.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria: - Subjects with moderate Rosacea (Global Severity Score of 3), - Subjects willing to stop their current rosacea medication for at least 2 weeks - Subjects must have an established routine of cosmetics application (e.g. must have been using the same facial foundation for at least 3 months and it is not expected to change during the study) - Subjects must be willing to use their routine facial foundation and not change products while on study Exclusion Criteria: - Subjects who do not routinely wear facial foundation - Subjects who failed to undergo a washout period of 14 days for the use of topical rosacea therapy, (for example: metronidazole, azelaic acid, sulfacetamide) - Subjects who are unwilling to stop their current rosacea medications for 2 weeks

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Metronidazole Gel
Topical, Once daily for 2 weeks

Locations
Country Name City State
United States Dermatology Consulting Services High Point North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Secondary Assessment of Cosmetic Appearance by Investigator Baseline and Week 2
Secondary Assessment of Cosmetic Appearance by Subject Baseline and Week 2
Secondary Erythema Severity Baseline and Week 2
Secondary Investigator Global Severity Score Baseline and Week 2
Secondary Tolerability Assessments and incidence of adverse events 2 weeks
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