ADEMETIONINE IN DIFFERENT COMBINATION REGIMENS TO TREAT ROSACEA: RESULTS FROM A RANDOMIZED, PROSPECTIVE CLINICAL TRIAL

Introduction: Rosacea is characterized by transient or persistent facial erythema, telangiectasia, papules and pustules and is classified into 4 subtypes: erythematoteleangiectatic (stage I), papulopustular (stage II), phymatous (stage III), and ocular rosacea. Objective: The study assessed the efficacy of different combinations of oral and topical medications, combined or not with ademetionine, in rosacea. Methods: This randomized, open label, prospective and exploratory study was conducted in 110 healthy male subjects of at least 18 years of age with stage I, stage II or stage III rosacea. Efficacy and safety of different basic (BCR) and complex (basic regimen + ademetionine, CCR) combinations of oral and topical rosacea medications were assessed throughout histopathological, immunohistochemical and clinical methods. Results: Multiple combination regimens using topical and oral medications significantly improved stage I and stage II/III rosacea. Improvement on a histological, immunohistochemical and clinical level was significantly superior (p < 0.05) when ademetionine was added. Recurrence of stage I or stage II/III rosacea was significantly less frequent (p < 0.05) in patients who received the CCR treatment regimens. No systemic adverse event was observed. Irritation was reported in 9 patients in the stage I group during the first 3 to 7 days of application of azelaic acid 15% gel: 5 patients (16.7%) in the CCR group, and 4 patients (20%) in the BCR group. No local adverse events were reported in the stage II/III patient group. Conclusion: Ademetionine may be a sparring partner in the treatment of rosacea using combination treatments.