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

NCT07744516 | Completed

• 1 other identifier: DA-OZOAQUA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Change in SCORAD score from baseline at days 7 and 14

  The primary efficacy outcome is the total SCORAD (Scoring Atopic Dermatitis) score, a widely validated instrument for the clinical assessment of atopic dermatitis. Three SCORAD assessments are performed throughout the study: at baseline, day 7, and day 14. The SCORAD index comprises three domains: \- SCORAD A: Extent This domain assesses the percentage of body surface area affected. In patients younger than 2 years of age, age-specific anatomical weightings for the paediatric population are applied. \- SCORAD B: Intensity This domain includes the clinical assessment of six dermatological signs: erythema, oedema, oozing/crusting, excoriation, lichenification, and xerosis. Each item is scored on an ordinal scale from 0 to 3. \- SCORAD C: Subjective symptoms This domain assesses the perceived severity of pruritus and sleep disturbance, each quantified on a scale from 0 to 10. \- The total SCORAD score is calculated using the standard formula: SCORAD = A/5 + (7 × B)/2 + C

  14 days

Secondary Outcomes (4)

• Number and percentage of patients achieving a SCORAD response at days 7 and 14 relative to baseline

  14 days

• Change in IDQoL score from baseline at day 7

  7 days

• Number and percentage of patients requiring rescue medication during the 14-day follow-up period

  14 days

• Number of days of rescue medication use during the 14-day follow-up period.

  14 days

Other Outcomes (2)

• Adverse events during the follow-up period

  14 days

• Treatment-related tolerability and cosmetic acceptability

  14 days

Study Arms (2)

Ozoaqua® Ozonated Oil

EXPERIMENTAL

Blend of ozonated olive and sunflower vegetable oils.

Other: ozonated oil

Non-ozonated vegetable oil

PLACEBO COMPARATOR

The same lipid vehicle, without ozonation.

Other: non-ozonated oil

Interventions

ozonated oil OTHER

Ozoaqua® Ozonated Oil

Ozoaqua® Ozonated Oil

non-ozonated oil OTHER

Same lipid vehicle, without ozonation.

Non-ozonated vegetable oil

Eligibility Criteria

• Age: 1 Month - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Laboratorios Ozoaqua: lead

Study Sites (3)

Alcantarilla-Sangonera Primary Care Centre

Alcantarilla, Spain

Location

Novelda Primary Care Centre

Novelda, Spain

Location

Torrevieja Hospital

Torrevieja, Spain

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: September 22, 2021
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Locations

ES (3)