NCT06997718

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This exploratory study is meant to assess the efficacy of a product in diabetic patients presenting foot xerosis and superficial fissures This exploratory study will be conducted as randomized, comparative study in parallel groups. In order to perform this clinical study, 60 female/male subjects, aged between 18 and 75 years old, with controlled type 1 or 2 diabetes and presenting foot xerosis and superficial fissures, are enrolled. The subjects are randomly divided in two groups, (Group I or Group II), where one group applies the test product and another group applies comparative product. The subjects apply the investigational/comparator products to both feet, twice a day, in the mornings and evenings, for 28 consecutive days. 3 visits are planned : * Visit 1: Inclusion (D1) * Visit 2: Intermediate visit (D5 ±2) * Visit 3: End-of-study visit (D28 ±2)

Conditions

• Diabetic Foot Xerosis

Interventions

Type	Name	Description
OTHER	RV5075A MF6793	Twice daily applications on both feet. The product will be applied according to randomization on the entire feet in a sufficient amount.
OTHER	CO5075A	Twice daily applications on both feet. The product will be applied according to randomization on the entire feet in a sufficient amount.

Timeline

• Start date: 2025-02-18
• Primary completion: 2025-11-17
• Completion: 2025-11-17
• First posted: 2025-05-30
• Last updated: 2025-11-24

Locations

1 site across 1 country: Portugal