RosaceaNCT05815511
Clinical Trial to Evaluate the Effect of a Probiotic Mixture on the Rosacea Evolution
A study testing Probiotic mixture in people with Rosacea and Rosacea Papular Type, run by Bionou Research, S.L. at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea, Rosacea Papular Type, Rosacea, Papulopustular
- What is being tested?
- Probiotic mixture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 3 sitesSpain
- Study dates
- 19 Oct 2022to 3 Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Eguren Dermatology and Aesthetics Clinic
Madrid, Madrid, 28006
MiBioPath UCAM Research Group
Murcia, Murcia, 30107
Gavín Dermatologists Clinic
Vigo, Pontevedra, 36201
About this study
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
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).
Read the 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.
- Conditions
- Rosacea, Rosacea Papular Type, Rosacea, Papulopustular
- Being tested
- Probiotic mixture, Placebo
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic mixtureDietary supplement
Oral capsule consumption once a day for 12 weeks
PlaceboDietary supplement
Oral capsule consumption once a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Probiotic mixture in oral capsule format with selected strains in concentrations equal to or greater than 1x10^10 cfu/dose. Receives: Dietary Supplement: Probiotic mixture |
| Placebo group | Placebo comparator | Maltodextrin in oral capsule format Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
The treatments considered will be any topical or systemic treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start19 Oct 2022
- Primary completion17 Apr 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial randomized, double-blind, and placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionou Research, S.L.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815511
- Sponsor's protocol ID
- ROS.PROB
- Status last verified
- Sep 2025
- First submitted
- 4 Apr 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No