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

Galderma

Status and phase

Completed

Phase 4

Conditions

Rosacea

Treatments

Drug: doxycycline (Oracea®) 40 mg modified release as monotherapy

Drug: doxycycline (Oracea®) 40 mg modified release as add-on therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00892281

US10120

Details and patient eligibility

About

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.

Enrollment

1,421 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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