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

Phase 4

Completed

• Conditions: Rosacea
• Interventions: Drug: Metronidazole gel 1%

• Registration Number: NCT00436527
• Lead Sponsor: Galderma R&D

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 Timeline

• Study Start: 2006-08
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Study First Submitted: 2007-02-16
• Study First Submitted QC: 2007-02-16
• Study First Posted: 2007-02-19
• Status Verified: 2008-04
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Metronidazole gel 1%	-

Primary Outcome Measures

Name	Time	Method
Six replicate Corneometer CM 825 measurements	8 hours

Secondary Outcome Measures

Name	Time	Method
Adverse events	1 day

Trial Locations

Locations (1)

Colorado Springs Research Center; 🇺🇸 Colorado Springs, Colorado, United States