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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668655
First Posted: April 29, 2008
Last Update Posted: September 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
  Purpose
The purpose of this study is to determine the cosmetic appearance of metronidazole gel (MetroGel®) 1% with commonly marketed facial foundations.

Condition Intervention
Rosacea Drug: Metronidazole Gel

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%

Resource links provided by NLM:


Further study details as provided by Galderma Laboratories, L.P.:

Secondary Outcome Measures:
  • Assessment of Cosmetic Appearance by Investigator [ Time Frame: Baseline and Week 2 ]
  • Assessment of Cosmetic Appearance by Subject [ Time Frame: Baseline and Week 2 ]
  • Erythema Severity [ Time Frame: Baseline and Week 2 ]
  • Investigator Global Severity Score [ Time Frame: Baseline and Week 2 ]
  • Tolerability Assessments and incidence of adverse events [ Time Frame: 2 weeks ]

Enrollment: 30
Study Start Date: February 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: MetroGel® 1%

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Sample
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668655


Locations
United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00668655     History of Changes
Other Study ID Numbers: US10086
First Submitted: April 25, 2008
First Posted: April 29, 2008
Last Update Posted: September 13, 2012
Last Verified: September 2012

Keywords provided by Galderma Laboratories, L.P.:
Rosacea, metronidazole

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents