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

NCT ID: NCT06997718

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-18
• Study Completion Date: 2025-11-17

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Test group

Group Type: EXPERIMENTAL

RV5075A MF6793

Intervention Type: OTHER

Twice daily applications on both feet. The product will be applied according to randomization on the entire feet in a sufficient amount.

Comparative group

Group Type: ACTIVE_COMPARATOR

CO5075A

Intervention Type: OTHER

Twice daily applications on both feet. The product will be applied according to randomization on the entire feet in a sufficient amount.

Interventions

RV5075A MF6793

Twice daily applications on both feet. The product will be applied according to randomization on the entire feet in a sufficient amount.

Intervention Type: OTHER

CO5075A

Twice daily applications on both feet. The product will be applied according to randomization on the entire feet in a sufficient amount.

Intervention Type: OTHER

Eligibility Criteria

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).

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Inovapotek

Porto, , Portugal

Countries

Portugal

Other Identifiers

RV5075A20240673

Identifier Type: -

Identifier Source: org_study_id