Skin Health and Effectiveness of Standardized Skin Care Regimens in Nursing Home Residents

PD Dr. Jan Kottner

Status: Completed

Conditions: Xerosis Cutis

Treatments: Other: Cetaphil® Restoraderm; Other: Excipial

Study type: Interventional

Funder types: Other

Identifiers

NCT02216526

CRC-SP-A-15

Details and patient eligibility

About

Residents of institutional long-term care facilities are at high risk for developing skin and tissue diseases, e.g. xerosis cutis (including pruritus), infections (e.g., tinea pedis, candidiasis), chronic wounds or neoplastic changes (e.g. actinic keratosis, malignant melanoma) but there are few epidemiological figures about the actual frequencies of these conditions in nursing homes. Therefore, in the first part of this study we aim at measuring key dermatological conditions and associated health and functional status, and the skin care practice of aged nursing home residents ("prevalence study").

Basic skin care interventions are believed to reduce skin dryness and to enhance skin health. Thus, the second aim of this study is to investigate the effectiveness of two structured skin care regimens compared to the routine standard skin care on skin health in nursing home residents ("intervention study").

The study will be conducted in a random sample of seven out of approximately 300 institutional long term care facilities of the federal state of Berlin.

Enrollment: 133 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

"Prevalence study"

• Living in the nursing home at the time of data collection;
• Being 65+ years;
• Written informed consent (or by legal representative);

Additional inclusion criteria for the "intervention study"

• Overall dry skin score (ODS) of 2 to 4 at the right and left leg;
• Willingness and ability to fulfil the study requirements.

Exclusion criteria

"Prevalence study"

• Residents at the end of life (dying persons).

Additional exclusion criteria for the "intervention study"

• Any dermatological condition or skin affection, e.g. acute weeping, excoriated or inflammatory dermatitis, or skin treatment which may interfere with the study assessments at the discretion of the investigator;
• Any unstable acute or chronic pathology or condition that may interfere with the study conduct at the discretion of the investigator;
• Any use of topical drugs on the investigational areas two weeks prior to inclusion;
• Systemic application of corticosteroids, antihistamine or other anti-inflammatory drugs;
• Known allergy or intolerance to any ingredient of the study products, e.g. urea.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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133 participants in 3 patient groups

Cetaphil® Restoraderm

Experimental group

Description:

Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks

Treatment:

Other: Cetaphil® Restoraderm

Excipial

Experimental group

Description:

Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks

Treatment:

Other: Excipial

Standard skin care

No Intervention group

Description:

Usual skin care routine of the nursing home resident