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Foot Cream for the Care of Dry and Cracked Skin

NCT04474808 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-01-23

No results posted yet for this study

Summary

In healthy people, but especially in people with diabetes, dry and cracked skin areas on the feet can occur. It is believed that the appearance of dry skin results from a deterioration in the barrier function due to (neuro-) physiological or neuropathic changes in the skin. The standard treatment for skin dryness mainly consists of appropriate care with moisturizing cleaning and care products to protect and restore the barrier function of the skin. Care products containing urea are often used here because urea reduces the feeling of dry and cracked skin due to its moisturizing, keratoplastic, bacteriostatic, antifungal, itch-relieving and proteolytic properties. However, urea-containing preparations can cause painful skin irritation and burning pain on cracked, injured or extremely inflamed skin. Comparable care effects with better tolerance were postulated for care creams enriched with L-arginine. Therefore, a newly developed cream containing 4% L-arginine for the care of dry and cracked skin should be tested in comparison to a conventional care cream containing 5% urea.

Conditions

Interventions

OTHER

L-Arginin containing foot cream

The participants apply one foot (randomized assignment) with the study cream twice a day (morning and evening) over a period of six weeks.

OTHER

Urea-containing foot cream

The participants apply one foot (randomized assignment) with the control cream twice a day (morning and evening) over a period of six weeks.

Sponsors & Collaborators

  • Bionatural GmbH

    collaborator UNKNOWN

  • West German Center of Diabetes and Health

    lead OTHER

Principal Investigators

  • Stephan Martin, MD · West German Centre of Diabetes and Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT04474808 on ClinicalTrials.gov