ORCA - Oracea® for Rosacea: A Community-based Assessment

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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 the treatment of rosacea.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma Laboratories, L.P.
• Treatments: Doxycycline

Criteria

Inclusion Criteria:

• Males and females aged 18 and older

• Subjects with diagnosis of rosacea (IGA of 2 to 4)

Exclusion Criteria:

• 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