Xerosis Cutis
Conditions
Keywords
Diabetes type II
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?
Interventions
OTHER10% 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.
OTHER10% 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.
Sponsors
Galderma R&D
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Single Blind (Investigator) Non-Randomized 60 \[Anticipated\]
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Overall Dry Skin Score | Baseline; Day 28±2 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin barrier | Day 0, Day 14±1,Day 28±2 | Transepidermal water loss: Measurement using the Tewameter® Three replicate measurements; according to the Technical Procedures G01\_A1\_V01 g/m2/h |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stratum corneum hydration | Day 28 | Stratum corneum hydration - Measurement using the Corneometer at Day 28 |
| Skin surface pH | Day 0 , Day 14, Day 28 | Skin surface pH Measurement using the pH-Meter® Three replicate measurements; according to the Technical Procedures G01\_A4\_V01 |
| Epidermal thickness | D28 | 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 |
| Elasticity/Stiffness | Day 28 | Elasticity/Stiffness Measurement using Cutometer® at day 28 |
| Callus | Day 0, Day 28 | Callus * Clinical evaluation by study investigator * Classification of Callus severity according to Hashmi et al. 2015 |
| Cracks/ Fissures | Day 0, Day 28 | Cracks/ Fissures * Clinical evaluation by study investigator * Classification according to Oe et al. 2012 |
| lipids | Day 0, Day 28 | Oxidative stress on lipids Measurement according to sampling method of Synelvia (Version 2) |
| Skin surface topography | Day 0, Day 28±2 | Skin surface topography - Measurement using Visioscan® |
Countries
Germany
Outcome results
None listed