An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%
1 other identifier
observational
30
1 country
1
Brief Summary
The purpose of this study is to determine the cosmetic appearance of metronidazole gel (MetroGel®) 1% with commonly marketed facial foundations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 25, 2008
CompletedFirst Posted
Study publicly available on registry
April 29, 2008
CompletedJuly 29, 2022
September 1, 2012
29 days
April 25, 2008
July 28, 2022
Conditions
Keywords
Outcome Measures
Secondary Outcomes (5)
Assessment of Cosmetic Appearance by Investigator
Baseline and Week 2
Assessment of Cosmetic Appearance by Subject
Baseline and Week 2
Erythema Severity
Baseline and Week 2
Investigator Global Severity Score
Baseline and Week 2
Tolerability Assessments and incidence of adverse events
2 weeks
Study Arms (1)
1
Female Subjects aged 20 to 75 inclusive, with a diagnosis of moderate (Global Severity Score of 3) Rosacea
Interventions
Eligibility Criteria
Community Sample
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (1)
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
Related Publications (1)
Draelos ZD, Colon 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.
PMID: 21699130DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ronald W Gottschalk, MD
Galderma R&D
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2008
First Posted
April 29, 2008
Study Start
February 1, 2008
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
July 29, 2022
Record last verified: 2012-09