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

NCT06997718 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-11-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Pierre Fabre Dermo Cosmetique

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-18
Primary Completion
2025-11-17
Completion
2025-11-17

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06997718 on ClinicalTrials.gov