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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rosacea, Rosacea Papular Type, Rosacea, Papulopustular

Intervention / Treatment
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* Dietary Supplement: Probiotic mixture
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinical trial randomized, double-blind, and placebo-controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic group<br>Probiotic mixture in oral capsule format with selected strains in concentrations equal to or greater than 1x10^10 cfu/dose. | Dietary Supplement: Probiotic mixture<br>* Oral capsule consumption once a day for 12 weeks<br>|
| Placebo Comparator: Placebo group<br>Maltodextrin in oral capsule format | Dietary Supplement: Placebo<br>* Oral capsule consumption once a day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Investigator's Global Assessment (IGA) index score at 6, 12 and 24 weeks | IGA index measures the severity of rosacea Score range is from 0 to 6 according to the severity of the disease 0=clear; 1=minimum; 2=mild; 3=mild-moderate; 4=moderate; 5=moderate-severe; 6=severe | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Clinician Erythema Assessment (CEA) scale at 6, 12 and 24 weeks | CEA scale measures the severity of rosacea Score range is from 0 to 4 according to the severity of the disease 0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe | 24 weeks | 
| Number of days using concomitant treatments during the 12 weeks of intervention | The number of days and the dose of concomitant treatments applied during the study will be counted, especially taking into account the consumption of: Doxycycline Isotreninoin Ivermectin | 12 weeks | 
| Treatments used during the 12 weeks after completion of study treatment. | The number of days and the dose of treatments applied during the 12 weeks after completion the study will be counted | 12 weeks | 
| Changes from baseline in Dermatology Life Quality Index (DLQI) at 6 and 12 weeks | DLQI measures the impact rosacea has on your quality of life The index has 10 questions. Each question answered with Very much is counted with 3 points, A lot with 2, Little with 1, and Not at all as 0. The score obtained can range between 0 and 30 points, this being the worst possible score. | 12 weeks | 
| Study treatment compliance rate at 6 and 12 weeks. | The treatment adherence is collected, checking the number of remaining capsules in each of the visits | 12 weeks |