Oral Doxycycline (Oracea) for Rosacea Treatment Evaluated in ORCA Study

By Hilary Baldwin, MD

Brooklyn, New York 11201

Physician (MD, DO), Dermatology

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Recently publicized results of the ORCA study, the largest clinical study of rosacea to date, showed that the treatment of rosacea subtype 2 (papulopustular rosacea) with Oracea® (doxycycline 40mg) lead to a significant reduction in pustules and papules.
This improvement in rosacea symptoms was seen when Oracea® was used alone (monotherapy) or in combination wither other topical medications, such as metronidazole (MetroGel®) or azelaic acid (Finacea®).

According to rosacea expert and study investigator Hilary Baldwin, M.D., “These results could change the way physicians treat rosacea.” Dr. Hilary Baldwin added that “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.”

The rosacea study evaluated 1421 patients with mild to severe papulopustular rosacea (rosacea subtype 2).

Oracea® is an oral medication that was developed to isolate doxycycline’s anti-inflammatory properties. This sub-antimicrobial dose, also called anti-inflammatory dose doxycycline, does not kill bacteria and does not lead to bacterial resistance. (Oracea® is a unique formulation of 30-mg immediate-release doxycyline and 10-mg delayed-release beads.)

ORCA stands for “Oracea® for Rosacea: A Community-Based Assessment”.

n the ORCA study, results found that the side effect profile of Oracea®, even in large populations, was consistent with that seen in controlled, clinical trials, with the most frequently reported side effects being mild to moderate nausea and diarrhea.

Rosacea is a chronic inflammatory skin disorder that primarily affects the face. It is prevalent amongst fair-skinned individuals who are 30 to 65 years old.  It often appears as skin lesions redness, visible blood vessels, papules and pustules in the middle of the face (forehead, nose, cheeks). Increased redness or flushing may result from certain rosacea triggers, such as alcohol, spicy food, sun exposure and hot showers. Stinging, burning and sensitivity of the skin and an intolerance to cosmetics are also very common and in some cases the eyes can become red, dry and itchy. There is presently no cure for rosacea, but topical and oral medications, as well as laser and light treatments, may reduce its signs and symptoms. Early diagnosis and treatment of rosacea can prevent its progression.

Oracea® is the only FDA approved oral medication for the treatment of rosacea. The ORCA trial was sponsored by Galderma Laboratories L.P., the manufacturer of  Oracea®. More information about the ORCA Trial is available from Galderma.