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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Xerosis Cutis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Cetaphil® Restoraderm

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

Group Type EXPERIMENTAL

Cetaphil® Restoraderm

Intervention Type OTHER

Excipial

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

Group Type EXPERIMENTAL

Excipial

Intervention Type OTHER

Standard skin care

Usual skin care routine of the nursing home resident

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cetaphil® Restoraderm

Intervention Type OTHER

Excipial

Intervention Type OTHER

Eligibility Criteria

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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);

* 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).

* 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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes