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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00668655
First received: April 25, 2008
Last updated: September 11, 2012
Last verified: September 2012
History of Changes
  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:

MedlinePlus related topics: Cosmetics Rosacea
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • Assessment of Cosmetic Appearance by Subject [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  • Erythema Severity [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  • Investigator Global Severity Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  • Tolerability Assessments and incidence of adverse events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 75 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Galderma Laboratories, L.P.

Additional 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
Study First Received: April 25, 2008
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 16, 2013