An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%
Information source: Galderma Laboratories, L.P.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rosacea
Intervention: Metronidazole Gel (Drug)
Phase: N/A
Status: Completed
Sponsored by: Galderma Laboratories, L.P. Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.
Summary
The purpose of this study is to determine the cosmetic appearance of metronidazole gel
(MetroGel®) 1% with commonly marketed facial foundations.
Clinical Details
Official title: An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%
Study design: Case-Only, Prospective
Secondary outcome: Assessment of Cosmetic Appearance by InvestigatorAssessment of Cosmetic Appearance by Subject Erythema Severity Investigator Global Severity Score Tolerability Assessments and incidence of adverse events
Detailed 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.
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Dermatology Consulting Services, High Point, North Carolina 27262, United States
Additional Information
Starting date: February 2008
Ending date: March 2008
Last updated: April 28, 2008
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