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

NCT02216526 | Completed Results

• 1 other identifier: CRC-SP-A-15
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Xerosis Cutis

Keywords

Skin health; Nursing; Long-term care

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Overall Dry Skin Score (ODS)

  Clinical assessment of the presence or severity of skin dryness using a five point rating scale at right lower leg. The Overall Dry Skin score is a clinical assessment of the presence and severity of skin dryness using a five-point scale. A score of '0' indicates no skin dryness, whereas a score of '4' indicates advanced skin roughness, large scales, inflammation and cracks.

  Baseline; Day 56+/-4

Secondary Outcomes (34)

• Stratum Corneum Hydration (SCH)

  Baseline, Day 56 +/- 4

• Transepidermal Water Loss (TEWL)

  Baseline, Day 56 +/- 4

• Skin Surface pH

  Baseline, Day 56 +/- 4

• Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6 Hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Baseline

  Baseline

• Number of Participants With a Pressure Ulcer at Baseline

  Baseline

Study Arms (3)

Cetaphil® Restoraderm

EXPERIMENTAL

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

Other: Cetaphil® Restoraderm

Excipial

EXPERIMENTAL

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

Other: Excipial

Standard skin care

NO INTERVENTION

Usual skin care routine of the nursing home resident

Interventions

Cetaphil® Restoraderm OTHER

Cetaphil® Restoraderm

Excipial OTHER

Excipial

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• "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.

You may not qualify if:

• "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;
• Systemic application of corticosteroids, antihistamine or other anti-inflammatory drugs;
• Known allergy or intolerance to any ingredient of the study products, e.g. urea.

Sponsors & Collaborators

• PD Dr. Jan Kottner: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (5)

• Gabriel S, Hahnel E, Blume-Peytavi U, Kottner J. Prevalence and associated factors of intertrigo in aged nursing home residents: a multi-center cross-sectional prevalence study. BMC Geriatr. 2019 Apr 15;19(1):105. doi: 10.1186/s12877-019-1100-8.

  PMID: 30987588 DERIVED

• Hahnel E, Blume-Peytavi U, Trojahn C, Kottner J. Associations between skin barrier characteristics, skin conditions and health of aged nursing home residents: a multi-center prevalence and correlational study. BMC Geriatr. 2017 Nov 13;17(1):263. doi: 10.1186/s12877-017-0655-5.

  PMID: 29132305 DERIVED

• Hahnel E, Blume-Peytavi U, Trojahn C, Dobos G, Jahnke I, Kanti V, Richter C, Lichterfeld-Kottner A, Garcia Bartels N, Kottner J. Prevalence and associated factors of skin diseases in aged nursing home residents: a multicentre prevalence study. BMJ Open. 2017 Sep 24;7(9):e018283. doi: 10.1136/bmjopen-2017-018283.

  PMID: 28947467 DERIVED

• Hahnel E, Blume-Peytavi U, Trojahn C, Dobos G, Stroux A, Garcia Bartels N, Jahnke I, Lichterfeld-Kottner A, Neels-Herzmann H, Klasen A, Kottner J. The effectiveness of standardized skin care regimens on skin dryness in nursing home residents: A randomized controlled parallel-group pragmatic trial. Int J Nurs Stud. 2017 May;70:1-10. doi: 10.1016/j.ijnurstu.2017.02.006. Epub 2017 Feb 7.

  PMID: 28214613 DERIVED

• Kottner J, Hahnel E, Trojahn C, Stroux A, Dobos G, Lichterfeld A, Richter C, Blume-Peytavi U. A multi-center prevalence study and randomized controlled parallel-group pragmatic trial to compare the effectiveness of standardized skin care regimens on skin health in nursing home residents: a study protocol. Int J Nurs Stud. 2015 Feb;52(2):598-604. doi: 10.1016/j.ijnurstu.2014.11.007. Epub 2014 Nov 15.

  PMID: 25443420 DERIVED

Limitations and Caveats

Residents, care givers, and study personnal was not blinded. Skin measurements were not conducted under standardized conditions.

Results Point of Contact

• Title: PD Dr. Jan Kottner
• Organization: Charité Universitätsmedizin Berlin, Germany

jan.kottner@charite.de

+49 (0)30 450 518 218

Study Officials

• Ulrike Blume-Peytavi, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientific Director Clinical Research Center for Hair and Skin Science

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: August 15, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 13, 2018
• Results First Posted: April 13, 2018

Record last verified: 2018-04

Locations

DE (1)