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

Xerosis Cutis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05046015
• Other study ID #: RD.03.SPR.109799
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 2017

Study information

• Verified date: February 2017
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

diabetics and non-diabetics

• Age 40 to 75 years

• Moderate (categories 3 and 4), severe (category 5) dry skin according to the classification of Rogers et al. 1989

• Degree of dryness comparable on both feet (maximum 1 category difference)

• BMI between 18.5 and 34.9 kg/m2 (normal weight to class I obesity)

• Able to understand and comply with the study requirements

• additionally only for diabetics: Diabetes mellitus type 2 for at least 3 years according to Patient

Exclusion Criteria:

• diabetics and non-diabetics

• Any kind of adverse foot condition except xerosis like nail injury, ulceration, (suspected) infection including fungal infection

• History of adverse foot condition except xerosis and tinea pedis, like nail injury, ulceration, pain

• Mild xerosis cutis of feet (categories 1 and 2 according to Rogers et al. 1989)

• Severe xerosis cutis of feet (category 6 according to Rogers et al. 1989)

• Gait problems

• Other non-controlled chronic and/or acute skin disease except xerosis (e.g. atopic dermatitis, psoriasis, tinea pedis)

• Unstable chronic systemic disease (e.g. hypertension, renal insufficiency)

• Acute systemic disease (e.g. infection)

• Body temperature > 38°C

• Pain anywhere

• Wear of compression stockings at any time

• Use of topical steroids

• Use of skin care leave-on products on the feet in the previous 2 weeks

• Known hypersensitivity or allergy to product ingredients

• Drugs that might affect sweating (oral corticosteroids, psychoactive drugs)

• Topical treatments other than the study products on the test areas within14 days prior Day 0 and during the course of the study

• Pedicure/ medical foot care 14 days prior D 0 and during the course of the study

• Any condition/ circumstance (e.g. cognitive impairment, visual impairment) that might interfere with study compliance in the opinion of the investigator

• Current participation in another clinical study

• Subject is institutionalized because of legal or regulatory order

• additionally only for non-diabetics: Diabetes mellitus type 2 according to Patient

• additionally only for diabetics:

• Charcot osteoarthropathy

• Neuropathy tested with a Semmes-Weinstein monofilament (according to Bakker et al. 2012)

• Absence of pedal pulses (1) Posterior tibial artery (2) Dorsalis pedis artery

Related Conditions & MeSH terms

• Xerosis Cutis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Charité Universitatsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stratum corneum hydration	Stratum corneum hydration - Measurement using the Corneometer at Day 28	Day 28
Other	Skin surface pH	Skin surface pH; Measurement using the pH-Meter® Three replicate measurements; according to the Technical Procedures G01_A4_V01	Day 0 , Day 14, Day 28
Other	Epidermal thickness	Epidermal thickness; Measurement using OCT taking one image/ visit/ test area Mean of three epidermal thickness measurements; according to the Technical Procedures G04_A1_V01 µm	D28
Other	Skin surface topography	Skin surface topography - Measurement using Visioscan®	Day 0, Day 28±2
Other	Elasticity/Stiffness	Elasticity/Stiffness Measurement using Cutometer® at day 28	Day 28
Other	lipids	Oxidative stress on lipids Measurement according to sampling method of Synelvia (Version 2)	Day 0, Day 28
Other	Callus	Callus; Clinical evaluation by study investigator; Classification of Callus severity according to Hashmi et al. 2015	Day 0, Day 28
Other	Cracks/ Fissures	Cracks/ Fissures; Clinical evaluation by study investigator; Classification according to Oe et al. 2012	Day 0, Day 28
Primary	Change from Baseline in Overall Dry Skin Score	Clinical assessment of the presence or severity of skin dryness using a 7 point scale at the sole of the foot (randomized). A score of '0' indicated normal skin/no sign of dryness, whereas a score of '6' indicates large-scale plates, deep erythematous fissures and cracks	Baseline; Day 28±2
Secondary	Skin barrier	Transepidermal water loss: Measurement using the Tewameter®; Three replicate measurements; according to the Technical Procedures G01_A1_V01 g/m2/h	Day 0, Day 14±1,Day 28±2