Clinical Research Directory
Browse clinical research sites, groups, and studies.
Clinical Trial to Evaluate the Efficacy and Safety of an Ozonated Oil in Atopic Dermatitis
Sponsor: Laboratorios Ozoaqua
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
ozonated oil
Ozoaqua® Ozonated Oil
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