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

Launched by BIONOU RESEARCH, S.L. · Apr 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special mixture of probiotics on a skin condition called rosacea, specifically the papulopustular type. Rosacea can cause redness, swelling, and small bumps on the face. In this trial, researchers will treat participants with either the probiotic mixture or a placebo (a sugar pill that looks the same but has no active ingredients) for 12 weeks to see how it affects their rosacea. The study involves three visits: the first one at the start, the second at 6 weeks, and the final visit at 12 weeks.

To join the trial, participants must be at least 18 years old and have a diagnosis of papulopustular rosacea with a certain level of severity. However, individuals who are pregnant, breastfeeding, or have certain allergies or other skin conditions won't be eligible. During the trial, participants will be closely monitored and will need to follow the guidelines provided by the study team. It's a great opportunity for those looking for new treatment options for their rosacea while contributing to medical research.

Gender

ALL

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.