In vivo evaluation of topical formulations containing asiaticoside for treatment of morphea

Abstract

Cutaneous Scleroderma or Morphea is an inflammatory, autoimmune and chronic disease characterized by skin thickening and fibrosis of the tissues involved. There is still no specific and consensual treatment for Cutaneous Scleroderma. Literature studies describe the Asiaticoside constituent, extracted from the Centella asiatica plant, as a potential active for the treatment of morphea lesions, acting in the reduction of the inflammatory and fibrotic process. Skin bioengineering methods have been extensively explored as they assist in the clinical diagnosis of the disease and in the monitoring of treatment in a non-invasive and objective way. Thus, this study aims to evaluate the in vivo effects of the application of topical formulations containing the active ingredient Asiaticoside in patients with morphea through non-invasive skin bioengineering techniques. For this, the developed emulsions will be evaluated from the centrifugation and pH tests and their organoleptic characteristics. For the study, 20 patients will be recruited at the Collagenosis Outpatient Clinic of the Hospital de Clínicas da Unicamp. After signing the informed consent form, the lesions of each patient will be treated, twice a day, for 4 months, with the formulations without (control group) and with (treatment group) the addition of the active. The project was accepted by the Unicamp Ethics Committee. The effectiveness of these formulations will be evaluated clinically by a dermatologist, subjectively by the patient through a questionnaire and objectively by methods of cutaneous bioengineering and skin imaging. The data obtained will be analyzed by the appropriate normality test and compared with a level of statistical significance when p <0.05. (AU)