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

Bionou Research

Status: Enrolling

Conditions: Rosacea Papular Type; Rosacea; Rosacea, Papulopustular

Treatments: Dietary Supplement: Probiotic mixture; Dietary Supplement: Placebo

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05815511

ROS.PROB

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

Probiotic mixture in oral capsule format with selected strains in concentrations equal to or greater than 1x10\^10 cfu/dose.

Treatment:

Dietary Supplement: Probiotic mixture

Placebo group

Placebo Comparator group

Description:

Maltodextrin in oral capsule format

Treatment:

Dietary Supplement: Placebo