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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

April 25, 2008
September 11, 2012
February 2008
March 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00668655 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%
An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%

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

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Community Sample
Rosacea
Drug: Metronidazole Gel
Topical, Once daily for 2 weeks
Other Name: MetroGel® 1%
1
Female Subjects aged 20 to 75 inclusive, with a diagnosis of moderate (Global Severity Score of 3) Rosacea
Intervention: Drug: Metronidazole Gel
Draelos ZD, Colón LE, Preston N, Johnson LA, Gottschalk RW. The appearance of facial foundation cosmetics applied after metronidazole gel 1%. Cutis. 2011 May;87(5):251-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Female
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00668655
US10086
No
Galderma Laboratories, L.P.
Galderma Laboratories, L.P.
Not Provided
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
Galderma Laboratories, L.P.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP