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An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%

Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT00668655
Collaborator
(none)
30
Enrollment
1
Location
29
Duration (Days)
31.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the cosmetic appearance of metronidazole gel (MetroGel®) 1% with commonly marketed facial foundations.

Condition or Disease Intervention/Treatment Phase
  • Drug: Metronidazole Gel

Detailed Description

Evaluate the relationship between treatment with MetroGel® 1% and cosmetic performance with the Subjects' usual cosmetic products. It is expected that the female subjects will be able to use their routine cosmetics after application without affecting the cosmetic product's performance or causing side effects.

Study Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
1

Female Subjects aged 20 to 75 inclusive, with a diagnosis of moderate (Global Severity Score of 3) Rosacea

Drug: Metronidazole Gel
Topical, Once daily for 2 weeks
Other Names:
  • MetroGel® 1%

    		•

    Outcome Measures

    Primary Outcome Measures

      Secondary Outcome Measures

      1. Assessment of Cosmetic Appearance by Investigator [Baseline and Week 2]

      2. Assessment of Cosmetic Appearance by Subject [Baseline and Week 2]

      3. Erythema Severity [Baseline and Week 2]

      4. Investigator Global Severity Score [Baseline and Week 2]

      5. Tolerability Assessments and incidence of adverse events [2 weeks]

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      20 Years to 75 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Subjects with moderate Rosacea (Global Severity Score of 3),

      • Subjects willing to stop their current rosacea medication for at least 2 weeks

      • Subjects must have an established routine of cosmetics application (e.g. must have been using the same facial foundation for at least 3 months and it is not expected to change during the study)

      • Subjects must be willing to use their routine facial foundation and not change products while on study

      Exclusion Criteria:

      • Subjects who do not routinely wear facial foundation

      • Subjects who failed to undergo a washout period of 14 days for the use of topical rosacea therapy, (for example: metronidazole, azelaic acid, sulfacetamide)

      • Subjects who are unwilling to stop their current rosacea medications for 2 weeks

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Dermatology Consulting Services High Point North Carolina United States 27262

      Sponsors and Collaborators

      • Galderma R&D

      Investigators

      • Study Director: Ronald W Gottschalk, MD, Galderma R&D

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Galderma R&D
      ClinicalTrials.gov Identifier:
      NCT00668655
      Other Study ID Numbers:
      • US10086
      First Posted:
      Apr 29, 2008
      Last Update Posted:
      Jul 29, 2022
      Last Verified:
      Sep 1, 2012
      Keywords provided by Galderma R&D
      Rosacea, metronidazole
      Additional relevant MeSH terms:
      Rosacea
      Metronidazole

      Study Results

      No Results Posted as of Jul 29, 2022