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

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.
 
ClinicalTrials.gov Identifier: NCT00436527
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : July 29, 2022
Sponsor:
Information provided by:
Galderma R&D

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Rosacea Drug: Metronidazole gel 1% Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MetroGel 1% Hydration Study: A Kinetic Regression Study
Study Start Date : August 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Arms and Interventions
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Arm Intervention/treatment
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%


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

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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
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United States, Colorado
Colorado Springs Research Center
Colorado Springs, Colorado, United States, 80915
Sponsors and Collaborators
Galderma R&D
Investigators
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Study Director: Ronald W Gottschalk, MD Galderma Laboratories, LP
More Information
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Responsible Party: Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00436527    
Other Study ID Numbers: US10041
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: April 2008
Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Metronidazole
Anti-Infective Agents
 Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents