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COMPLETED
NCT07744516
NA

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

Sponsor: Laboratorios Ozoaqua

View on ClinicalTrials.gov

Summary

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.

Official title: Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of an Ozonated Oil in Atopic Dermatitis

Key Details

Gender

All

Age Range

1 Month - 6 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2021-09-22

Completion Date

2026-04-10

Last Updated

2026-08-04

Healthy Volunteers

No

Interventions

OTHER

ozonated oil

Ozoaqua® Ozonated Oil

OTHER

non-ozonated oil

Same lipid vehicle, without ozonation.

Locations (3)

Alcantarilla-Sangonera Primary Care Centre

Alcantarilla, Spain

Novelda Primary Care Centre

Novelda, Spain

Torrevieja Hospital

Torrevieja, Spain