Rosacea
Conditions
Keywords
Rosacea, metronidazole
Brief summary
The purpose of this study is to determine the cosmetic appearance of metronidazole gel (MetroGel®) 1% with commonly marketed facial foundations.
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.
Interventions
Topical, Once daily for 2 weeks
Sponsors
Galderma R&D
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed