An interventional study of Probiotic mixture and Placebo in Rosacea, Rosacea Papular Type and Rosacea, Papulopustular, sponsored by Bionou Research, S.L.. Completed at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Bionou Research, S.L. · Not applicable, Interventional, and Treatment
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).
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.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's enrollment of 70 is above the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →Bionou Research, S.L. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Probiotic mixture in oral capsule format with selected strains in concentrations equal to or greater than 1x10\^10 cfu/dose.
Dietary Supplement: Probiotic mixture
Maltodextrin in oral capsule format
Dietary Supplement: Placebo
Oral capsule consumption once a day for 12 weeks
Oral capsule consumption once a day for 12 weeks
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)
Time frame: 12 weeks
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
The treatments considered will be any topical or systemic treatment
Time frame: 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
The treatments considered will be any systemic treatment
Time frame: 12 weeks
Number and percentage of cases that need any treatment (topical or systemic) and number of days during the treatment period (12 weeks)
The number of treatment days and the number of participants prescribed treatment by the dermatologist will be counted The treatments considered will be any topical or systemic treatment
Time frame: 12 weeks
Number and percentage of cases that need systemic treatment and number of days during the treatment period (12 weeks)
The number of treatment days and the number of participants prescribed systemic treatment by the dermatologist will be counted The treatments considered will be any systemic treatment
Time frame: 12 weeks
Number and percentage of cases that need topical treatment and number of days during the treatment period (12 weeks)
The number of days and the number of participants prescribed topical treatment by the dermatologist will be counted The treatments considered will be any topical treatment
Time frame: 12 weeks
Number and percentage of cases responding to the treatment according to the 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. It will be considered a treatment response in DLQI scale when the score is 0-5 points (no effect or mild effect in the quality of life)
Time frame: 12 weeks
Number and percentage of cases responding to the treatment according to the IGA index score, comparing the baseline with the visit at 24 weeks (post-treatment follow-up)
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 when the participant improves by at least 2 categories in this index and the final score is 0-1 points (clear and almost clear)
Time frame: 24 weeks
Number and percentage of cases requiring any treatment (topical or systemic), along with the number of days, covering the total period (24 weeks) and the post-treatment follow-up period (from week 12 to 24)
The number of treatment days and the number of participants prescribed treatment by the dermatologist will be counted The treatments considered will be any topical or systemic treatment
Time frame: 24 weeks
Number and percentage of cases requiring systemic treatment, along with the number of days, covering the total period (24 weeks) and the post-treatment follow-up period (from week 12 to 24)
The number of treatment days and the number of participants prescribed systemic treatment by the dermatologist will be counted The treatments considered will be any systemic treatment
Time frame: 24 weeks
Number and percentage of cases requiring topical treatment, along with the number of days, covering the total period (24 weeks) and the post-treatment follow-up period (from week 12 to 24)
The number of treatment days and the number of participants prescribed topical treatment by the dermatologist will be counted The treatments considered will be any topical treatment
Time frame: 24 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
Time frame: 12 weeks
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
Time frame: 12 weeks
Ran from Oct 2022 to primary completion in Apr 2025, 29 months.
Of 42 interventional studies with no phase under Rosacea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's 29 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Bionou Research, S.L.