NCT05046015

Comparison Dry Foot Skin Between Diabetic and Non-diabetic Subjects and the Effects of Two Cosmetic Foot Care Products

Comparing Dry to Very Dry and Cracked Foot Skin Between Diabetic and Non-diabetic Subjects and the Effects of Two Cosmetic leave-on Foot Products: an Exploratory Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The overall aims of this study are to compare the structure and function of dry to very dry and cracked foot skin between diabetic and nondiabetic subjects and to evaluate the effects of two cosmetic leave-on products on dry and fissured diabetic foot skin. Specific issues are: Are there any differences between the morphological and functional characteristics of dry to very dry and cracked skin foot between diabetic and nondiabetic subjects? What are the effects of a 4-week once daily application of an intensive care foot ointment (urea 10% foot ointment) or foot lotion (10% Urea foot lotion) on the skin barrier and on clinical signs of dryness and fissures?

Detailed description

A long existing diabetes mellitus type II is often associated with a number of skin changes. Xerosis Cutis is the most common skin alteration. The risk of diabetics of developing a foot ulcer is estimated to be 15%. Very dry and cracked skin represents an additional risk factor, so that adequate skin care is a widely recommended intervention in diabetic patients. But there are only few studies investigating the skin barrier structure and function in diabetic patients. Available study results seem to suggest, that for instance sebum content, stratum corneum hydration, and pH are associated with Diabetes mellitus. The overall aims of this study are to compare the structure and function of dry to very dry and cracked foot skin between diabetic and nondiabetic subjects and to evaluate the effects of two cosmetic leave-on products on dry and fissured diabetic foot skin. Specific issues are: Are there any differences between the morphological and functional characteristics of dry to very dry and cracked skin foot between diabetic and nondiabetic subjects? What are the effects of a 4-week once daily application of an intensive care foot ointment (urea 10% foot ointment) or foot lotion (10% Urea foot lotion) on the skin barrier and on clinical signs of dryness and fissures?

Conditions

• Xerosis Cutis

Interventions

Type	Name	Description
OTHER	10% Urea foot lotion	During the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser "Cetaphil® Restoraderm Body Wash" and apply the product "Excipial® U10 Lipolotion 10% Urea" once daily in the evening by themselves.
OTHER	10% Urea foot ointment	During the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser "Cetaphil® Restoraderm Body Wash" and apply the product "Excipial® U10 ointment10% Urea" once daily in the evening by themselves.

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2021-09-16
• Last updated: 2021-09-16

Locations

1 site across 1 country: Germany