Evaluation of the Effects of the Product RV5075A-MF6793 in Diabetic Patients Presenting Foot Xerosis and Superficial Fissures, an Exploratory Study.

Launched by PIERRE FABRE DERMO COSMETIQUE · May 22, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a new product called RV5075A-MF6793 for people with diabetes who have dry, cracked skin on their feet, known as foot xerosis. The study will involve 60 men and women between the ages of 18 and 75 who have well-controlled type 1 or type 2 diabetes and are experiencing this foot condition. Participants will be randomly assigned to either use the new product or a comparison product, applying it to both feet twice a day for 28 days.

To be eligible for the study, individuals must have a certain level of dryness on their feet and must not have any uncontrolled diabetes or other foot issues that could affect the results. Throughout the study, participants will attend three visits: one to join the study, one after five days, and a final visit after 28 days. This trial aims to see how effective the new product is in improving foot dryness and cracks, which can be a common problem for people with diabetes.

Gender

ALL

Eligibility criteria

• Main Inclusion criteria:
• • Gender: Male/Female;
• • Age: 18 to 75 years old;
• • Presenting skin phototype between I and IV according to the Fitzpatrick phototyping scale;
• • Presenting controlled type 1 or 2 diabetes;
• • Presenting xerosis intensity on feet is rated as 6 according to the Xerosis Assessment Scale (XAS).
• Main Non-inclusion criteria:
• • Subject with uncontrolled diabetes and/or with diabetes complications
• • Subjects with any foot condition or medical history liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational products according to the investigator's assessment
• • Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational products according to the investigator's assessment