NCT05815511

Clinical Trial to Evaluate the Effect of a Probiotic Mixture on the Rosacea Evolution

A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of a Probiotic Mixture on the Evolution and Treatment of Rosacea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Bionou Research, S.L. · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The three visits that make up the study and the actions to be carried out in each of them are described below: Visit 1 (initial; week 0) Once the informed consent is signed, a doctor trained for the study performs the initial interview where it is verified that the patient meets all the inclusion criteria and none of the exclusion criteria and their medical history.The investigator will proceed to assign the patient the next study participant number and, according to a previously prepared randomization list, the treatment that they will receive during the study will be assigned. The investigator will assess the severity and symptoms of rosacea according to the Investigator's Global Assessment (IGA) and Clinician Erythema Assessment (CEA) scales. The patient will also complete a questionnaire to assess the impact on quality of life due to the disease: Dermatology Life Quality Index (DLQI). Visit 2 (intermediate; week 6) In this intermediate visit, in addition to assessing the symptoms of the disease with the detailed scales, the investigator will record the adverse events reported by the patient, as well as the concomitant treatments used. Also, the treatment compliance rate will be calculated by counting the capsules returned by the patient. Visit 3 (final; week 12) In the final visit, the same actions will be carried out as in the intermediate visit, evaluating the severity of the disease and the remaining capsules will be collected, to calculate treatment compliance, concomitant treatments and adverse events. Visit 4 (post-treatment follow-up; week 24) During this visit, the symptoms of the disease will be assessed with the two scales used in the study and the treatments that the patient has required during the 12 weeks after the end of the study treatment will be counted.

Conditions

• Rosacea
• Rosacea Papular Type
• Rosacea, Papulopustular

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic mixture	Oral capsule consumption once a day for 12 weeks
DIETARY_SUPPLEMENT	Placebo	Oral capsule consumption once a day for 12 weeks

Timeline

• Start date: 2022-10-19
• Primary completion: 2025-04-17
• Completion: 2025-07-03
• First posted: 2023-04-18
• Last updated: 2025-09-19

Locations

3 sites across 1 country: Spain