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

Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT00436527
Collaborator
(none)
26
Enrollment
1
Location
1
Arm

Study Details

Study Description

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
  • 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

Study Type:
Interventional
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 :
Aug 1, 2006
Actual Primary Completion Date :
Aug 1, 2006
Actual Study Completion Date :
Aug 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Other: 1

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Six replicate Corneometer CM 825 measurements [8 hours]

    Secondary Outcome Measures

    1. Adverse events [1 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Colorado Springs Research Center Colorado Springs Colorado United States 80915

    Sponsors and Collaborators

    • Galderma R&D

    Investigators

    • Study Director: Ronald W Gottschalk, MD, Galderma Laboratories, LP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00436527
    Other Study ID Numbers:
    • US10041
    First Posted:
    Feb 19, 2007
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Apr 1, 2008
    Additional relevant MeSH terms:
    Rosacea
    Metronidazole

    Study Results

    No Results Posted as of Jul 29, 2022