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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | Probiotic mixture in oral capsule format with selected strains in concentrations equal to or greater than 1x10^10 cfu/dose. |
|
| Placebo group | Placebo Comparator | Maltodextrin in oral capsule format |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic mixture | Dietary Supplement | Oral capsule consumption once a day for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eguren Dermatology and Aesthetics Clinic | Madrid | Madrid | 28006 | Spain | ||
| MiBioPath UCAM Research Group |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Clinical trial randomized, double-blind, and placebo-controlled
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| Placebo |
| Dietary Supplement |
Oral capsule consumption once a day for 12 weeks |
|
The treatments considered will be any systemic treatment |
| 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 | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 12 weeks |
| Murcia |
| Murcia |
| 30107 |
| Spain |
| Gavín Dermatologists Clinic | Vigo | Pontevedra | 36201 | Spain |