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 range18 Years

SexALL

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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.

What they're measuring

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

Timeframe: 12 weeks

Trial details

NCT IDNCT05815511

SponsorBionou Research, S.L.

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2025-04-17

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