ORCA was designed to reflect real world conditions when managing PPR in a large, diverse population of rosacea patients undergoing routine care at 271 community-based medical practices.
Galderma said that the study was also designed to evaluate the safety and effectiveness of Oracea, when used alone or when the physician believed that it should be added-on to existing topical therapies for rosacea.
Galderma claimed that Oracea’s, sub-antimicrobial, 40mg formulation of doxycycline (30mg immediate-release and 10mg delayed-release beads) was developed to isolate doxycycline’s anti-inflammatory properties to treat papulopustular rosacea and is the only US Food and Drug Administration (FDA) approved oral medication for rosacea treatment in the disease category.
Oracea is a sub-antimicrobial dose of doxycycline, and has demonstrated no evidence of bacterial resistance.
Oracea was evaluated in the ORCA trial in two arms, effectiveness of monotherapy, effectiveness of add-on therapy and additionally, impact on the quality of life was also evaluated.
State University of New York Medical Center, Brooklyn, Hilary Baldwin said that the results could change the way physicians treat rosacea because the study’s size and design was intended to reflect patient care in the real world, not in an optimised clinical trial environment.
"ORCA confirms the safety of Oracea and its effectiveness as a papulopustular rosacea treatment, even as monotherapy, with 3 out of 4 patients showing significant improvements over 12 weeks of treatment," Baldwin said.