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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in Overall Dry Skin Score
研究概览
简要总结
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?
详细描述
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
non diabetic
Control Group of 20 non-diabetics. Skin measurements, evaluation of skin dryness and sampling of skin particles will be performed
moderate dryness-diabetic
Experimental: Diabetics with moderate dryness. Intervention Group of 20 diabetics with moderate dryness
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.
干预措施: 10% Urea foot lotion (Other)
severe dryness- diabetic
Intervention Group of 20 diabetics with severe dryness 10% Urea foot ointment During the course of the study participants cleanse their feet once daily using the mild cleanser "Cetaphil® Restoraderm Body Wash" and apply the product "Excipial® Fuss Salbe 10% Urea" on both feet once daily in the evening by themselves.
干预措施: 10% Urea foot ointment (Other)
结局指标
主要结局
Change from Baseline in Overall Dry Skin Score
时间窗: 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
次要结局
- Skin barrier(Day 0, Day 14±1,Day 28±2)