Status:
COMPLETED
ORCA - Oracea® for Rosacea: A Community-based Assessment
Lead Sponsor:
Galderma R&D
Conditions:
Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to assess the effectiveness, safety, subject satisfaction and quality of life with Oracea® when used as monotherapy or as add-on therapy to existing topical regimens for...
Eligibility Criteria
Inclusion
- Males and females aged 18 and older
- Subjects with diagnosis of rosacea (IGA of 2 to 4)
Exclusion
- Subjects who used a topical or systemic acne treatment within 4 months of the baseline visit (retinoids and isotretinoin)
- Subjects who used a topical or systemic antibiotic within 4 weeks of the baseline visit
- Subjects who had laser or IPL (intense pulsed light) treatments within 3 months of the baseline visit and/or who plan to have these treatments during the study
- Subjects who have a known hypersensitivity to tetracyclines or ingredients of the add on medications
- Subjects who have stomach or GI problems, kidney disease or have an active systemic fungal infection or a vaginal yeast infection are excluded
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
1421 Patients enrolled
Trial Details
Trial ID
NCT00892281
Start Date
April 1 2009
End Date
October 1 2009
Last Update
August 25 2022
Active Locations (1)
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1
REGISTRAT® - MAP1, Inc. (CRO)
Lexington, Kentucky, United States, 40504-3276