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

Completed · Not applicable

Conditions studied: Atopic Dermatitis (AD), Atopic Dermatitis (Eczema)

In brief

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.

Key facts

Study ID

NCT07744516

Run by

Laboratorios Ozoaqua

People needed

50

Starts

2021-09-22

Expected to finish

2026-04-10

Last updated by the study team

2026-08-04

Who can join

Age: 0 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alcantarilla-Sangonera Primary Care Centre — Alcantarilla, Spain
• Novelda Primary Care Centre — Novelda, Spain
• Torrevieja Hospital — Torrevieja, Spain

Full record on ClinicalTrials.gov

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