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

NCT07744516 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-04

No results posted yet for this study

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.

Conditions

  • Atopic Dermatitis (AD)
  • Atopic Dermatitis (Eczema)

Interventions

OTHER

ozonated oil

Ozoaqua® Ozonated Oil

OTHER

non-ozonated oil

Same lipid vehicle, without ozonation.

Sponsors & Collaborators

  • Laboratorios Ozoaqua

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2026-04-10
Completion
2026-04-10

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07744516 on ClinicalTrials.gov