Evaluating a Probiotic Mixture for Rosacea Treatment
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of a Probiotic Mixture on the Evolution and Treatment of Rosacea
This study is testing whether a special mix of probiotics can help people with rosacea feel better over 12 weeks compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bionou Research, S.L. Research network |
| Locations | 3 sites (Vigo, Pontevedra and 2 other locations) |
| Trial ID | NCT05815511 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to assess the effects of a probiotic mixture on the evolution of rosacea over a 12-week period. Participants will be randomly assigned to receive either the probiotic or a placebo, with evaluations conducted at the start, at six weeks, and at the end of the treatment. The severity of rosacea will be measured using established scales, and the impact on patients' quality of life will also be assessed. The study aims to provide insights into the efficacy of probiotics in managing rosacea symptoms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with papulopustular rosacea.
Not a fit: Patients with other dermatological conditions or those who have recently used antibiotics or probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, non-invasive option for managing rosacea symptoms.
How similar studies have performed: While the use of probiotics in dermatological conditions is emerging, this specific approach to treating rosacea is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of both sexes of an age equal to or greater than 18 years. * Patients diagnosed with papulopustular rosacea with a minimum score of 2 points according to the Investigator's Global Assessment (IGA) index. * Signature of informed consent by the patient Exclusion Criteria: * Pregnant, lactating, and/or women who do not agree to use an effective contraceptive method during the development of the study. * Allergy and/or intolerance to any of the components of the product under study. * Consumption of antibiotics in the previous two weeks. * Consumption of probiotics in the previous two months. * Isotretinoin use in the previous six months. * Light procedures (IPL, laser, Kleresca) in the previous three months. * Participation in other clinical studies in the previous two months. * Other dermatological pathologies.
Where this trial is running
Vigo, Pontevedra and 2 other locations
- Gavín Dermatologists Clinic — Vigo, Pontevedra, Spain (Recruiting)
- Eguren Dermatology and Aesthetics Clinic — Madrid, Spain (Recruiting)
- MiBioPath UCAM Research Group — Murcia, Spain (Recruiting)
Study contacts
- Study coordinator: Juan Gabriel Agüera Santos
- Email: juan.aguera@gmail.com
- Phone: +34 623022586
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.