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

Tracking Information

First Received Date ^ICMJE

April 25, 2008

Last Updated Date

April 28, 2008

Start Date ^ICMJE

February 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00668655 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assessment of Cosmetic Appearance by Investigator [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
Assessment of Cosmetic Appearance by Subject [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
Erythema Severity [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
Investigator Global Severity Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
Tolerability Assessments and incidence of adverse events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Prospective

Condition ^ICMJE

Rosacea

Intervention ^ICMJE

Drug: Metronidazole Gel

Study Arms / Comparison Groups

Female Subjects aged 20 to 75 inclusive, with a diagnosis of moderate (Global Severity Score of 3) Rosacea

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00668655

Responsible Party

Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.

Study ID Numbers ^ICMJE

US10086

Study Sponsor ^ICMJE

Galderma Laboratories, L.P.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, L.P.

Information Provided By

Galderma Laboratories, L.P.

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP