A Prevalence and Multi-center Randomized Parallel-group Pragmatic Trial to Compare the Effectiveness of Standardized Skin Care Regimens on Skin Health in Nursing Home Residents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 133
- Locations
- 2
- Primary Endpoint
- Change From Baseline in Overall Dry Skin Score (ODS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Cetaphil® Restoraderm
Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks
Intervention: Cetaphil® Restoraderm (Other)
Excipial
Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks
Intervention: Excipial (Other)
Standard skin care
Usual skin care routine of the nursing home resident
Outcomes
Primary Outcomes
Change From Baseline in Overall Dry Skin Score (ODS)
Time Frame: Baseline; Day 56+/-4
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.
Secondary Outcomes
- Number of Participants With Pressure Ulcer at Day 28 +/-3(Day 28 +/-3)
- Number of Participants With Skin Tears at Baseline(Baseline)
- Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3(Day 28 +/-3)
- Number of Participants With Pressure Ulcer at Day 56 +/-3(Day 56 +/-3)
- Skin Surface pH(Baseline, Day 56 +/- 4)
- Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline(Baseline)
- Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline(Baseline)
- Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3(Day 56 +/-3)
- Transepidermal Water Loss (TEWL)(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 Incontinence Associated Dermatitis (IAD) at Baseline(Baseline)
- Number of Participants With Skin Tears at Day 28 +/-3(Day 28 +/-3)
- Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3(Day 56 +/-3)
- Quality of Life Sum Score at Day 56 +/-3(Day 56 +/-3)
- Stratum Corneum Hydration (SCH)(Baseline, Day 56 +/- 4)
- Number of Participants With a Pressure Ulcer at Baseline(Baseline)
- Quality of Life Sum Score at Baseline(Baseline)
- Number of Participants With Skin Tears at Day 56 +/-3(Day 56 +/-3)
- Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline(Baseline)
- Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline(Baseline)
- Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3(Day 56 +/-3)
- Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3(Day 56 +/-3)
- Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline(Baseline)
- Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Baseline(Baseline)
- Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Baseline(Baseline)
- Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3(Day 56 +/-3)
- Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3(Day 56 +/-3)
- Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline(Baseline)
- Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline(Baseline)
- Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3(Day 56 +/-3)
- Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Day 56 +/-3(Day 56 +/-3)
- Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3(Day 56 +/-3)
- Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Day 56 +/-3(Day 56 +/-3)
- Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Day 56 +/-3(Day 56 +/-3)
Investigators
PD Dr. Jan Kottner
Scientific Director Clinical Research Center for Hair and Skin Science
Charite University, Berlin, Germany