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

NCT05046015 | Completed

• 1 other identifier: RD.03.SPR.109799
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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?

Conditions

Xerosis Cutis

Keywords

Diabetes type II

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Skin barrier

  Day 0, Day 14±1,Day 28±2

Other Outcomes (8)

• Stratum corneum hydration

  Day 28

• Skin surface pH

  Day 0 , Day 14, Day 28

• Epidermal thickness

  D28

Study Arms (3)

non diabetic

NO INTERVENTION

Control Group of 20 non-diabetics. Skin measurements, evaluation of skin dryness and sampling of skin particles will be performed

moderate dryness-diabetic

EXPERIMENTAL

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.

Other: 10% Urea foot lotion

severe dryness- diabetic

EXPERIMENTAL

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.

Other: 10% Urea foot ointment

Interventions

10% Urea foot lotion OTHER

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.

moderate dryness-diabetic

10% Urea foot ointment OTHER

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.

severe dryness- diabetic

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Charité Universitatsmedizin Berlin

Berlin, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ulrike Blume -Peytavi, Prof Dr.med

  Charité Universitatsmedizin Berlin

  PRINCIPAL INVESTIGATOR

• Ulrike Blume-Peytavi, Prof Dr.med

  Charité Universitatsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Blind (Investigator) Non-Randomized 60 \[Anticipated\]

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: September 16, 2021
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 16, 2021

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)