Clinical Trial to Evaluate the Efficacy and Safety of an Ozonated Oil in Atopic Dermatitis (NCT07744516) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial to Evaluate the Efficacy and Safety of an Ozonated Oil in Atopic Dermatitis
Spain50 participantsStarted 2021-09-22
Plain-language 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.
Who can participate
Age range
1 Month – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in SCORAD score from baseline at days 7 and 14