Efficacy and Safety of a Dermatological Soap containing Ozonated Sunflower Oil (OSO), Sulfur, or Sulfur plus OSO and a Dermatological Cream containing OSO in Subjects with Scabies

To evaluate the efficacy and safety of a dermatological soap containing OSO, sulfur, or sulfur plus OSO and a dermatological cream containing OSO for 21 days in subjects with Scabies.

This is a short-term, open-label, randomized, comparative study on three parallel groups treated with either dermatological soap with OSO + dermatological cream-OSO, or with sulfur soap +dermatological cream-OSO, or with sulfur-OSO dermatological soap + dermatological cream-OSO. The treatment duration was 21 days. The primary efficacy endpoint was clinical cure or improvement and negative dermatoscopy.

Secondary efficacy endpoints included a significant reduction in the total score of the Eczema Area and Severity Index (EASI) and the total score of the Visual Analogue Scale (VAS), while the improvement in the EuroQol Quality of Life Questionnaire was assessed as a collateral efficacy variable. Treatments were considered effective if, at the end of the study, they resulted in a cure or clinical improvement and a negative dermatoscopy result compared to baseline. The safety analysis included the effects on the physical examination and laboratory indicators investigated, as well as the reported adverse events, which were classified according to their severity and relationship to the treatment. Statistical analysis of all data was performed according to the intention-to-treat principle.

The study included 75 subjects of both sexes diagnosed with scabies, who were randomly assigned to three groups (25/group) treated with either dermatological soap with OSO and dermatological cream containing OSO, or with sulfur soap and dermatological cream containing OSO, or with sulfur-OSO dermatological soap and dermatological cream containing OSO, respectively. All groups had similar baseline characteristics. The mean age of the study population was 69 years, and the sex distribution showed a predominance of female subjects (68/75, or 90.7%). No subjects dropped out of the study. At the end of the 21-day treatment period, 100% (75/75) of the subjects treated with the respective therapies achieved cure or clinical improvement. Regarding the clinical cure rate (absence of pruritus and skin lesions) and negative dermatoscopy (no presence of the parasite) (primary efficacy variables), treatment with Sulfur-OSO Dermatological Soap+OSO Dermatological Cream produced a cure rate and negative dermatoscopy in 80% (20/25) of the subjects, higher than that achieved in the groups treated with Sulfur Soap+OSO Dermatological Cream (64%, 16/25 subjects) or with OSO Dermatological Soap+OSO Dermatological Cream (60%, 15/25 subjects). Regarding secondary efficacy variables, all groups achieved a significant reduction (p<0.0001) in the total score of the EASI Scale and the total score of the VAS Scale (for pruritus), and a significant increase (p<0.0001) in the total score of the EuroQol (collateral efficacy variable) versus baseline values. The treatments showed a satisfactory safety and tolerability profile, and only three subjects in the group treated with sulfur soap + dermatological cream with OSO reported an adverse event classified as mild (allergic contact dermatitis) during the study.

Treatment with Sulfur-OSO Dermatological Soap + OSO Dermatological Cream showed superior efficacy compared to treatments with Sulfur Soap + OSO Dermatological Cream or OSO Dermatological Soap + OSO Dermatological Cream, respectively, in subjects with Scabies. The treatments were safe and well-tolerated.