Clinical Trial to Evaluate the Effect of a Probiotic Mixture on the Rosacea Evolution (NCT05815511) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial to Evaluate the Effect of a Probiotic Mixture on the Rosacea Evolution
Spain70 participantsStarted 2022-10-19
Plain-language summary
The clinical trial has a randomized, double-blind, placebo-controlled design, in which the aim is to evaluate the effect of a probiotic mix, with a 12-week treatment, on the evolution of rosacea.
This 12 weeks of treatment are structured into three visits: Visit 1 (initial; week 0), Visit 2 (intermediate; week 6) and Visit 3 (final; week 12).
Who can participate
Age range
18 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:
* 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.
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
Number and percentage of cases responding to the treatment according to the Investigator's Global Assessment (IGA) index score, comparing the baseline with the visits at 6 and 12 weeks