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

Primary Purpose

Rosacea, Rosacea Papular Type, Rosacea, Papulopustular

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Probiotic mixture
Placebo
Sponsored by
Bionou Research, S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Gavín Dermatologists ClinicRecruiting
  • Eguren Dermatology and Aesthetics ClinicRecruiting
  • MiBioPath UCAM Research GroupRecruiting
  • Salamanca University Hospital. Dermatology Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic group

Placebo group

Arm Description

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

Maltodextrin in oral capsule format

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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.
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

Full Information

First Posted
April 4, 2023
Last Updated
April 4, 2023
Sponsor
Bionou Research, S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT05815511
Brief Title
Clinical Trial to Evaluate the Effect of a Probiotic Mixture on the Rosacea Evolution
Official Title
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of a Probiotic Mixture on the Evolution and Treatment of Rosacea
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
April 4, 2024 (Anticipated)
Study Completion Date
July 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bionou Research, S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea, Rosacea Papular Type, Rosacea, Papulopustular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical trial randomized, double-blind, and placebo-controlled
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic group
Arm Type
Experimental
Arm Description
Probiotic mixture in oral capsule format with selected strains in concentrations equal to or greater than 1x10^10 cfu/dose.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Maltodextrin in oral capsule format
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic mixture
Intervention Description
Oral capsule consumption once a day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Oral capsule consumption once a day for 12 weeks
Primary Outcome Measure Information:
Title
Changes from baseline in Investigator's Global Assessment (IGA) index score at 6, 12 and 24 weeks
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Changes from baseline in Clinician Erythema Assessment (CEA) scale at 6, 12 and 24 weeks
Description
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
Time Frame
24 weeks
Title
Number of days using concomitant treatments during the 12 weeks of intervention
Description
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
Time Frame
12 weeks
Title
Treatments used during the 12 weeks after completion of study treatment.
Description
The number of days and the dose of treatments applied during the 12 weeks after completion the study will be counted
Time Frame
12 weeks
Title
Changes from baseline in Dermatology Life Quality Index (DLQI) at 6 and 12 weeks
Description
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.
Time Frame
12 weeks
Title
Study treatment compliance rate at 6 and 12 weeks.
Description
The treatment adherence is collected, checking the number of remaining capsules in each of the visits
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Number of adverse events at 6 and 12 weeks
Description
Adverse events reported by patients during follow-up at week 6 and week 12 visits are recorded
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Navarro Moratalla
Phone
+34 865780170
Email
laura.navarro@bioithas.com
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Gabriel Agüera Santos
Phone
+34 623022586
Email
juan.aguera@gmail.com
Facility Information:
Facility Name
Gavín Dermatologists Clinic
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36201
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan García Gavín, MD
Phone
+34 986 11 77 27
Facility Name
Eguren Dermatology and Aesthetics Clinic
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Eguren Michelena, MD
Phone
+34 630 74 38 00
Facility Name
MiBioPath UCAM Research Group
City
Murcia
ZIP/Postal Code
30107
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Navarro López, PhD
Phone
+34 695845742
Facility Name
Salamanca University Hospital. Dermatology Service
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Rodríguez Baeza, MD
Email
daniel.rodriguez.baeza@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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