Clinical trial NCT06997718: Evaluation of the Effects of the Product RV5075A-MF6793 in Diabetic Patients Presenting Foot Xerosis and Superficial Fissures, an Exploratory Study.
Official title: Evaluation of the Effects of the Product RV5075A-MF6793 in Diabetic Patients Presenting Foot Xerosis and Superficial Fissures, an Exploratory Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Xerosis
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2025-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

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)


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

Primary outcomes:
measure: Xerosis intensity on both feet with XAS (Xerosis Assessment Scale)
timeFrame: Before (Day 1 Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
measure: Evolution of superficial fissures intensity on both feet with VAS (Visual Analog Scale)
timeFrame: After 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application compared to baseline (Day 1, Visit 1)
measure: Evolution of superficial fissures intensity on a target fissure with VAS (Visual Analog Scale)
timeFrame: After 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application compared to baseline (Day 1, Visit 1)
measure: Quality of Life evaluation by the patient
timeFrame: Before (Day 1, Visit 1), and after 28 (Visit 3) consecutive days of products' application
measure: Global soothing effect evaluation on feet
timeFrame: After the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
measure: Intensity of pruritus/itchiness on feet
timeFrame: 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
measure: Intensity of tingling on feet
timeFrame: 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
measure: Intensity of tightness on feet
timeFrame: 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
measure: Intensity of pain on feet
timeFrame: 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
measure: Skin hydration
timeFrame: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
measure: Standardized photographs of the target fissure of each subject to visually assess the evolution of the target fissure.
timeFrame: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
measure: Cosmetic satisfaction and perceived effect evaluation questionnaire
timeFrame: 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
measure: Standardized photograph of the selected foot of each subject is taken for illustrative purposes
timeFrame: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
measure: Compliance of the subject to the product
timeFrame: During the entire course of the study, from inclusion visit (Day 1), to the end-of-study visit (Day 28).
measure: Global assessment of the tolerance
timeFrame: At the end of the study (after 28 consecutive days of products' twice-daily application), or premature withdrawal
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Inovapotek
Study officials:
References: