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NCT00436527 Clinical Trial

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

Rosacea Clinical Trial

Official title:
MetroGel 1% Hydration Study: A Kinetic Regression Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00436527
Other study ID # US10041
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 2006
Est. completion date August 2006

Study information
Verified date April 2008
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date August 2006
Est. primary completion date August 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Colorado Springs Research Center Colorado Springs Colorado

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Six replicate Corneometer CM 825 measurements 8 hours
Secondary Adverse events 1 day
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