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

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

Tracking Information

• First Submitted Date: February 16, 2007
• First Posted Date: February 19, 2007
• Last Update Posted Date: July 29, 2022
• Study Start Date: August 2006
• Actual Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 11, 2008): Six replicate Corneometer CM 825 measurements [ Time Frame: 8 hours ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: April 11, 2008): Adverse events [ Time Frame: 1 day ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application
• Official Title: MetroGel 1% Hydration Study: A Kinetic Regression Study
• 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.
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Rosacea

Intervention

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%

Study Arms

1

Intervention: Drug: Metronidazole gel 1%

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 11, 2008): 26
• Original Enrollment: Not Provided
• Actual Study Completion Date: August 2006
• Actual Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00436527
• Other Study ID Numbers: US10041
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
• Original Responsible Party: Not Provided
• Current Study Sponsor: Galderma R&D
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Galderma R&D
• Verification Date: April 2008