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CompletedNCT00436527Updated Jul 29, 2022

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

A Phase 4 interventional study of Metronidazole gel 1% in Rosacea, sponsored by Galderma R&D. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-29.

Sponsored by Galderma R&D · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rosacea

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03

In context

Rosacea

225 studies on the registry are indexed under Rosacea; 19 are open to participants now.

This study's enrollment of 26 is below the median of 61 across 195 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.

Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

Exclusion Criteria:

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Other
    1

    Drug: Metronidazole gel 1%

Interventions

  • DrugMetronidazole gel 1%

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

    Also known as: MetroGel® 1%

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What researchers measure

Primary outcomes

  1. Six replicate Corneometer CM 825 measurements

    Time frame: 8 hours

Secondary outcomes

  1. Adverse events

    Time frame: 1 day

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Study locations

1 site
  • Colorado Springs Research Center
    Colorado Springs, Colorado 80915, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00436527
Lead sponsor
Galderma R&D
First posted
Feb 19, 2007
Start date
Aug 2006
Primary completion
Aug 2006
Completion
Aug 2006
Last update
Jul 29, 2022

Study contacts

Ronald W Gottschalk, MD
study director · Galderma Laboratories, LP

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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