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

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).

Study Overview

• Status: Recruiting
• Conditions: Rosacea; Rosacea, Papulopustular; Rosacea Papular Type
• Intervention / Treatment: Dietary supplement: Probiotic mixture; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Navarro Moratalla; Phone Number: +34 865780170; Email: laura.navarro@bioithas.com
• Study Contact Backup: Name: Juan Gabriel Agüera Santos; Phone Number: +34 623022586; Email: juan.aguera@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28006
    • Recruiting
    • Eguren Dermatology and Aesthetics Clinic
    • Contact: Cristina Eguren Michelena, MD; Phone Number: +34 630 74 38 00
  • Murcia, Spain, 30107
    • Recruiting
    • MiBioPath UCAM Research Group
    • Contact: Vicente Navarro López, PhD; Phone Number: +34 695845742
  • Salamanca, Spain, 37007
    • Not yet recruiting
    • Salamanca University Hospital. Dermatology Service
    • Contact: Daniel Rodríguez Baeza, MD; Email: daniel.rodriguez.baeza@gmail.com
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36201
      • Recruiting
      • Gavín Dermatologists Clinic
      • Contact: Juan García Gavín, MD; Phone Number: +34 986 11 77 27

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events at 6 and 12 weeks	Adverse events reported by patients during follow-up at week 6 and week 12 visits are recorded	12 weeks

Collaborators and Investigators

• Sponsor: Bionou Research, S.L.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Anticipated): April 4, 2024
• Study Completion (Anticipated): July 4, 2024

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: ROS.PROB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No