Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application

This study has been completed.

First Received on February 16, 2007. Last Updated on April 11, 2008 History of Changes

Sponsor:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00436527

Purpose

This eight-hour kinetic regression clinical study was conducted to assess the ability of MetroGel® 1% to deliver moisture to facial skin after a single application.

Condition	Intervention	Phase
Rosacea	Drug: Metronidazole gel 1%	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	MetroGel 1% Hydration Study: A Kinetic Regression Study

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Metronidazole

U.S. FDA Resources

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

Primary Outcome Measures:

Six replicate Corneometer CM 825 measurements [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Enrollment:	26
Study Start Date:	August 2006
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: Metronidazole gel 1% Applied once to a test site on the right or left cheek (as determined by a randomization design) Other Name: MetroGel® 1%

Detailed Description:

This eight-hour kinetic regression clinical study was conducted to assess the ability of MetroGel® 1% to deliver moisture to facial skin after a single application as measured by the Corneometer CM 825.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of moderate to severe rosacea, defined as the presence of at least moderate erythema with telangiectasia and a minimum of two inflammatory lesions

Exclusion Criteria:

Individuals with active symptoms of allergy (mild active seasonal allergies are acceptable) or atopic dermatitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436527

Locations

United States, Colorado
Colorado Springs Research Center
Colorado Springs, Colorado, United States, 80915

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, LP

More Information

No publications provided

Responsible Party:	Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00436527 History of Changes
Other Study ID Numbers:	US10041
Study First Received:	February 16, 2007
Last Updated:	April 11, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Rosacea
Skin Diseases
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 09, 2012