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

NCT06997718 | Completed

• 1 other identifier: RV5075A20240673
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (15)

• Xerosis intensity on both feet with XAS (Xerosis Assessment Scale)

  Evaluation performed by the investigator, giving 1 XAS score for both feet/patient (9 points scale, from 0 = Normal skin, to 8 =Skin with deep fissures).

  Before (Day 1 Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application

• Evolution of superficial fissures intensity on both feet with VAS (Visual Analog Scale)

  Evaluation performed by the investigator, giving 1 VAS score for both feet/patient (continuous sliding scale from 0 mm = no repair/no improvement to 100 mm = complete repair/full improvement).

  After 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application compared to baseline (Day 1, Visit 1)

• Evolution of superficial fissures intensity on a target fissure with VAS (Visual Analog Scale)

  Evaluation performed by the investigator specifically on the target fissure identified at the inclusion visit, on VAS (continuous sliding scale from 0 mm = no repair/no improvement to 100 mm = complete repair/full improvement).

  After 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application compared to baseline (Day 1, Visit 1)

• Quality of Life evaluation by the patient

  Filling by the patient of a 13-questions questionnaire about their quality of life related to their feet condition.

  Before (Day 1, Visit 1), and after 28 (Visit 3) consecutive days of products' application

• Global soothing effect evaluation on feet

  The global soothing is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no relief/no soothing effect to 100 mm = complete relief/total soothing effect)

  After the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application

• Intensity of pruritus/itchiness on feet

  The evolution of pruritus intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no itching or pruritus at all, to 100 mm = extreme itching, unbearable)

  Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application

• Intensity of tingling on feet

  The evolution of tingling intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no tingling sensation, to 100 mm = intense tingling, very uncomfortable)

  Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application

• Intensity of tightness on feet

  The evolution of tightness intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no tightness at all, to 100 mm = extreme tightness, uncomfortable)

  Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application

• Intensity of pain on feet

  The evolution of pain intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no pain at all, to 100 mm = extreme pain, debilitating)

  Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application

• Skin hydration

  Skin capacitance is assessed instrumentally by an expert, on the selected foot of each subject

  Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application

• Standardized photographs of the target fissure of each subject to visually assess the evolution of the target fissure.

  Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application

• Cosmetic satisfaction and perceived effect evaluation questionnaire

  Filling by the patient of a subjective evaluation questionnaire considering their cosmetic acceptability, and perceived efficacy towards the investigational/comparator product

  After the first application (Day 1, Visit 1), and after 5 (Visit 2), 15 (at home) and 28 (Visit 3) consecutive days of products' application

• Standardized photograph of the selected foot of each subject is taken for illustrative purposes

  Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application

• Compliance of the subject to the product

  Subjects fill in a subject diary (daily log) during the course of the study to record their compliance to the product.

  During the entire course of the study, from inclusion visit (Day 1), to the end-of-study visit (Day 28).

• Global assessment of the tolerance

  Global assessment of the tolerance is assessed by the investigator for each subject at the end of the study considering all individual adverse events and their characteristics, based on a 5-point scale (from excellent tolerance to bad tolerance).

  At the end of the study (after 28 consecutive days of products' twice-daily application), or premature withdrawal

Study Arms (2)

Test group

EXPERIMENTAL

Other: RV5075A MF6793

Comparative group

ACTIVE COMPARATOR

Other: CO5075A

Interventions

RV5075A MF6793 OTHER

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

Test group

CO5075A 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Inovapotek

Porto, 4200-135, Portugal

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The subjects are randomly divided in two groups, according to the randomization list, where one group applies the test product (product code: RV5075A), and another group applies comparative product (product code: CO5075A).

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 30, 2025
• Study Start: February 18, 2025
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

PT (1)