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

NCT05046015 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-09-16

No results posted yet for this study

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

Interventions

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.

OTHER

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.

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Ulrike Blume -Peytavi, Prof Dr.med · Charité Universitatsmedizin Berlin

  • Ulrike Blume-Peytavi, Prof Dr.med · Charité Universitatsmedizin Berlin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05046015 on ClinicalTrials.gov