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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00436527
First Posted: February 19, 2007
Last Update Posted: April 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Galderma Laboratories, L.P.
  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 4

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Six replicate Corneometer CM 825 measurements [ Time Frame: 8 hours ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 1 day ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00436527     History of Changes
Other Study ID Numbers: US10041
First Submitted: February 16, 2007
First Posted: February 19, 2007
Last Update Posted: April 14, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents