Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
Galderma Laboratories, L.P. Identifier:
First received: February 16, 2007
Last updated: April 11, 2008
Last verified: April 2008
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
Drug: Metronidazole gel 1%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00436527

United States, Colorado
Colorado Springs Research Center
Colorado Springs, Colorado, United States, 80915
Sponsors and Collaborators
Galderma Laboratories, L.P.
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, LP
  More Information

Responsible Party: Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P. Identifier: NCT00436527     History of Changes
Other Study ID Numbers: US10041
Study First Received: February 16, 2007
Last Updated: April 11, 2008

Additional relevant MeSH terms:
Skin Diseases
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents processed this record on April 28, 2017