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Clinical Trials/NCT00436527
NCT00436527CompletedPhase 4

MetroGel 1% Hydration Study: A Kinetic Regression Study

Galderma R&D1 site in 1 country26 target enrollmentStarted: August 2006Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
Six replicate Corneometer CM 825 measurements

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

1

Other

Intervention: Metronidazole gel 1% (Drug)

Outcomes

Primary Outcomes

Six replicate Corneometer CM 825 measurements

Time Frame: 8 hours

Secondary Outcomes

  • Adverse events(1 day)

Investigators

Sponsor Class
Industry

Study Sites (1)

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