Clinical Trial to Evaluate the Efficacy and Safety of an Ozonated Oil in Atopic Dermatitis

This clinical trial is designed to evaluate the efficacy, safety, and tolerability of a topical ozonated vegetable oil formulation in paediatric patients with mild-to-moderate atopic dermatitis. The study follows a randomised, double-blind, placebo-controlled design and compares clinical progression, as assessed using the SCORAD (Scoring Atopic Dermatitis) index, quality of life, as measured using the IDQoL (Infants' Dermatitis Quality of Life Index), and various safety and cosmetic acceptability outcomes over a 14-day follow-up period. In addition to conventional clinical efficacy endpoints, the study includes responder analyses and quality-of-life assessments to provide a more comprehensive characterisation of the potential therapeutic benefit of ozonated oil in this population.

Inclusion Criteria: * Male or female patients aged between 1 month and 6 years. * Clinical diagnosis of atopic dermatitis. * Active mild or moderate flare. * Baseline SCORAD score between 20 and 50 points. * Availability of parents or legal guardians to administer the treatment and complete the follow-up period. * Written informed consent provided by the parents or legal guardians. Exclusion Criteria: * Severe atopic dermatitis. * Clinically relevant active skin infection. * Recent use of systemic immunosuppressive treatments. * Serious concomitant diseases. * Known hypersensitivity to any component of the formulation. * Clinical conditions that could interfere with the interpretation of the therapeutic response.