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

NCT05815511 | Completed

• 1 other identifier: ROS.PROB
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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).

Conditions

Rosacea; Rosacea Papular Type; Rosacea, Papulopustular

Outcome Measures

Primary Outcomes (1)

• Number and percentage of cases responding to the treatment according to the Investigator's Global Assessment (IGA) index score, comparing the baseline with the visits at 6 and 12 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 It will be considered a treatment response in IGA scale when the participant improves by at least 2 categories in this index and the final score is 0-1 points (clear and almost clear)

  12 weeks

Secondary Outcomes (11)

• Number and percentage of cases responding to the treatment according to the IGA index score, analyzing the cases that received any topical or systemic treatment, comparing the baseline with the visits at 6 and 12 weeks

  12 weeks

• Number and percentage of cases responding to the treatment according to the IGA index score, analyzing the cases that received systemic treatment, comparing the baseline with the visits at 6 and 12 weeks

  12 weeks

• Number and percentage of cases that need any treatment (topical or systemic) and number of days during the treatment period (12 weeks)

  12 weeks

• Number and percentage of cases that need systemic treatment and number of days during the treatment period (12 weeks)

  12 weeks

• Number and percentage of cases that need topical treatment and number of days during the treatment period (12 weeks)

  12 weeks

Other Outcomes (1)

• Number of adverse events at 6 and 12 weeks

  12 weeks

Study Arms (2)

Probiotic group

EXPERIMENTAL

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

Dietary Supplement: Probiotic mixture

Placebo group

PLACEBO COMPARATOR

Maltodextrin in oral capsule format

Dietary Supplement: Placebo

Interventions

Probiotic mixture DIETARY_SUPPLEMENT

Oral capsule consumption once a day for 12 weeks

Probiotic group

Placebo DIETARY_SUPPLEMENT

Oral capsule consumption once a day for 12 weeks

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bionou Research, S.L.: lead

Study Sites (3)

Eguren Dermatology and Aesthetics Clinic

Madrid, Madrid, 28006, Spain

Location

MiBioPath UCAM Research Group

Murcia, Murcia, 30107, Spain

Location

Gavín Dermatologists Clinic

Vigo, Pontevedra, 36201, Spain

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Clinical trial randomized, double-blind, and placebo-controlled

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: October 19, 2022
• Primary Completion: April 17, 2025
• Study Completion: July 3, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

ES (3)