NCT00436527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2007

Completed
Last Updated

July 29, 2022

Status Verified

April 1, 2008

Enrollment Period

Same day

First QC Date

February 16, 2007

Last Update Submit

July 28, 2022

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

  • Six replicate Corneometer CM 825 measurements

    8 hours

Secondary Outcomes (1)

  • Adverse events

    1 day

Study Arms (1)

1

OTHER
Drug: Metronidazole gel 1%

Interventions

Metronidazole gel 1%DRUG

Applied once to a test site on the right or left cheek (as determined by a randomization design)

Also known as: MetroGel® 1%
1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with active symptoms of allergy (mild active seasonal allergies are acceptable) or atopic dermatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado Springs Research Center

Colorado Springs, Colorado, 80915, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ronald W Gottschalk, MD

    Galderma Laboratories, LP

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 16, 2007

First Posted

February 19, 2007

Study Start

August 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

July 29, 2022

Record last verified: 2008-04

Locations

US(1)