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

Pierre Fabre

Status: Completed

Conditions: Diabetic Foot Xerosis

Treatments: Other: RV5075A MF6793; Other: CO5075A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06997718

RV5075A20240673

Details and patient eligibility

About

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)

Enrollment: 62 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Test group

Experimental group

Treatment:

Other: RV5075A MF6793

Comparative group

Active Comparator group

Treatment:

Other: CO5075A