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

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.
ClinicalTrials.gov Identifier: NCT00668655
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : July 29, 2022
Information provided by (Responsible Party):
Galderma R&D

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
Rosacea 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.

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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 : February 2008
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Cosmetics Rosacea

Group/Cohort Intervention/treatment
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%

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

Information from the National Library of Medicine

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

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

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

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United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
Sponsors and Collaborators
Galderma R&D
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Study Director: Ronald W Gottschalk, MD Galderma R&D
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT00668655    
Other Study ID Numbers: US10086
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: September 2012
Keywords provided by Galderma R&D:
Rosacea, metronidazole
Additional relevant MeSH terms:
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Skin Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents