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

Sponsor:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00668655

Purpose

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

Condition	Intervention
Rosacea	Drug: Metronidazole Gel

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%

Resource links provided by NLM:

MedlinePlus related topics: Cosmetics Rosacea

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Metronidazole

U.S. FDA Resources

Further study details as provided by Galderma Laboratories, L.P.:

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	30
Study Start Date:	February 2008
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Female Subjects aged 20 to 75 inclusive, with a diagnosis of moderate (Global Severity Score of 3) Rosacea	Drug: Metronidazole Gel Topical, Once daily for 2 weeks

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

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Community Sample

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668655

Locations

United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, L.P.

More Information

No publications provided

Responsible Party:	Galderma Laboratories, L.P. ( Ronald W. Gottschalk, MD / Medical Director )
Study ID Numbers:	US10086
Study First Received:	April 25, 2008
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00668655 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Galderma Laboratories, L.P.:

Rosacea, metronidazole

Additional relevant MeSH terms:

Anti-Infective Agents
Metronidazole
Rosacea
Antiparasitic Agents
Antiprotozoal Agents

Radiation-Sensitizing Agents
Skin Diseases
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009