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

Information source: Galderma Laboratories, L.P.
ClinicalTrials.gov processed this data on August 23, 2015
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: Observational Model: Case-Only, Time Perspective: Prospective

Secondary outcome:

Assessment of Cosmetic Appearance by Investigator

Assessment 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
Last updated: September 11, 2012

Page last updated: August 23, 2015

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