NCT07744516Completed
Clinical Trial to Evaluate the Efficacy and Safety of an Ozonated Oil in Atopic Dermatitis
Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of an Ozonated Oil in Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 29 Jul 2026
- Start date
- 22 Sept 2021
- Primary completion date
- 10 Apr 2026
- Lead sponsor
- Laboratorios Ozoaqua
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07744516
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 22 Sept 2021 to the primary completion date, 10 Apr 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious concomitant diseases.
Other illness
- Clinically relevant active skin infection.
- Known hypersensitivity to any component of the formulation.
- Clinical conditions that could interfere with the interpretation of the therapeutic response.
Other
- Severe atopic dermatitis.
- Recent use of systemic immunosuppressive treatments.
Who the study is looking for
- 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.
Age in the registry: 1 month to 6 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alcantarilla-Sangonera Primary Care Centre Coordinator of this site? Confirm its status | Alcantarilla | Spain | Unknown status |
| Novelda Primary Care Centre Coordinator of this site? Confirm its status | Novelda | Spain | Unknown status |
| Torrevieja Hospital Coordinator of this site? Confirm its status | Torrevieja | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.