Clinical trial NCT05046015: Comparison Dry Foot Skin Between Diabetic and Non-diabetic Subjects and the Effects of Two Cosmetic Foot Care Products
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerosis Cutis
Keywords: Diabetes type II
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Blind (Investigator) Non-Randomized 60 \[Anticipated\]
Primary purpose: TREATMENT

Brief 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?

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Overall Dry Skin Score
timeFrame: Baseline; Day 28±2
Secondary outcomes:
measure: Skin barrier
timeFrame: Day 0, Day 14±1,Day 28±2
Other outcomes:
measure: Stratum corneum hydration
timeFrame: Day 28
measure: Skin surface pH
timeFrame: Day 0 , Day 14, Day 28
measure: Epidermal thickness
timeFrame: D28
measure: Skin surface topography
timeFrame: Day 0, Day 28±2
measure: Elasticity/Stiffness
timeFrame: Day 28
measure: lipids
timeFrame: Day 0, Day 28
measure: Callus
timeFrame: Day 0, Day 28
measure: Cracks/ Fissures
timeFrame: Day 0, Day 28
Locations:
city: Berlin
country: Germany
facility: Charité Universitatsmedizin Berlin
Study officials:
affiliation: Charité Universitatsmedizin Berlin
name: Ulrike Blume -Peytavi, Prof Dr.med
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité Universitatsmedizin Berlin
name: Ulrike Blume-Peytavi, Prof Dr.med
role: PRINCIPAL_INVESTIGATOR
References: