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

A pilot, randomised, double-blind, placebo-controlled clinical trial is conducted to evaluate the clinical efficacy, safety, and tolerability of a topical formulation based on ozonated vegetable oil in paediatric patients with mild-to-moderate atopic dermatitis.

The primary objective of the study is to evaluate the clinical efficacy of topical ozonated oil in reducing the severity of paediatric atopic dermatitis, as quantified by the change in the total SCORAD score from baseline to the follow-up visits, from both a continuous perspective, based on the absolute change in SCORAD, and a clinical-response perspective.

The secondary objectives are:

To evaluate the impact of treatment on atopic dermatitis-related quality of life using the IDQoL questionnaire.

To evaluate the proportion of patients achieving clinically meaningful improvements in SCORAD according to the minimal clinically important difference (MCID) criteria.

To quantify the need for rescue medication. To assess the safety and tolerability of the active formulation. To evaluate cosmetic acceptability and subjective satisfaction with the treatment.

The study follows a parallel, two-arm design, with participants randomly assigned to receive either the active formulation or placebo. The active treatment consists of a topical ozonated vegetable oil formulation, whereas the control group receives a placebo formulation containing the same non-ozonated lipid vehicle. The use of the same vehicle in both groups ensures cosmetic and organoleptic comparability between the formulations, thereby supporting the maintenance of blinding throughout the trial.

The study is conducted under double-blind conditions, such that neither the clinical investigators nor the patients' parents or legal guardians are aware of treatment allocation during follow-up. Formulation coding and randomisation assignments remain concealed until completion of the statistical analysis.

The total clinical follow-up period is 14 days, with assessments performed at three time points:

Baseline visit (Day 0) Follow-up visit (Day 7 ± 1) Final visit (Day 14 ± 2)

The data collected at each study visit are summarised below:

Baseline visit

Demographic variables Clinical and atopic history Dermatological history Baseline SCORAD assessment IDQoL questionnaire

Day 7 visit

Interim SCORAD assessment IDQoL questionnaire Adverse events Treatment adherence Rescue medication use

Day 14 visit

Final SCORAD assessment Adverse events Treatment adherence Rescue medication use Treatment satisfaction, tolerability, and cosmetic acceptability variables

The study is conducted at the paediatric outpatient clinics of Clínica Quirón Valencia, Torrevieja Hospital, and the Novelda and Alcantarilla-Sangonera Primary Care Centres.

The investigational product, corresponding to the active treatment, is Ozoaqua® Ozonated Oil. The comparator product, corresponding to placebo, consists of a formulation prepared using the same lipid vehicle but without ozonation. The oil is applied topically once every 12 hours, corresponding to two applications per day, to the affected areas throughout the 14-day study follow-up period. Although the management of atopic dermatitis during the study is based on the topical application of either the active product or the comparator, the use of rescue medication is permitted at the investigators' discretion.

The study population comprises paediatric patients with a clinical diagnosis of active mild-to-moderate atopic dermatitis. Eligible patients are between 1 month and 6 years of age and are required to meet clinical criteria consistent with atopic dermatitis, as determined by specialist medical assessment.

The total study sample comprises 50 patients.

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.