Official Title: “MetroGel 1% Hydration Study: A Kinetic Regression Study”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: August 2006

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1

Primary Measures

• Six replicate Corneometer CM 825 measurements
  • Time Frame: 8 hours
    Safety Issue?: No

Secondary Measures

• Adverse events
  • Time Frame: 1 day
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Galderma Laboratories, L.P.

Overall Clinical Trial Officials and Contacts

Ronald W Gottschalk, MD Study Director Galderma Laboratories, LP  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00436527

Study ID Number: US10041

ClinicalTrials.gov Identifier: NCT00436527

Health Authority: United States: Institutional Review Board