EVALUATION OF THE SOOTHING EFFECT OF A NATURAL FORMULATION ON RADIOTHERAPY INDUCED DERMATITIS. INSTRUMENTAL, CLINICAL AND PSYCHOLOGICAL ASSESSMENT

Aim of this work is to evaluate the potential efficacy of a topical product based on a combination of natural active ingredients on the reduction of the effects induced on the skin by radiotherapy. The product has been formulated accordingly to the most recent innovations of natural excipients and botanical actives. The combination of active ingredients comprises: a specific boswellia resin extract, standardized in boswellic acids, which are recognized potent anti-inflammatory compounds, formulated in a specific delivery system which was shown to ameliorate skin affinity; a specific lipophilic fraction of Sichuan pepper containing alpha hydroxyl-sanshool, a skin sensitivity modulator; a polysaccharide from tamarind with objectivized hydrating properties. The emulsifying, as well as the preservative system of the formulation, are once again of natural origin. Finally, the overall texture of the product results very light and easy to spread ameliorating the compliance of patients and the use on challenged skin areas. This experimental, double blind controlled trial, foresees the pre-application of the product one week prior to the beginning of the radiotherapy protocol once a day, twice daily during the radiotherapy treatment and again once a day in the two following weeks. The panel of enrolled patients comprises 40 women randomly assigned to the active group and 40 women randomly assigned to the best available treatment group, being this an emollient product standard-of-care used by the hospital. The skin toxicity induced by the treatment is evaluated by the clinical RTOG scoring system, and the severity and timing for the onset of the erythema represents the primary endpoint of the study. An additional primary endpoint is the overall quality of life of the patients which is evaluated by a scientific tool developed by the University of Padua, the “Padua Skin-related QoL Questionnaire” whose data collection and interpretation is followed by psychologists. Additionally, a score defined as PGIC (Patient’s Global Impression of Change) has been collected to evaluate the perceived amelioration and skin care support.