N/A
N=133
Skin Health and Effectiveness of Standardized Skin Care Regimens in Nursing Home Residents
Xerosis Cutis
Bottom Line
View on ClinicalTrials.gov: NCT02216526 ↗Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Change From Baseline in Overall Dry Skin Score (ODS) — -0.9; -1.2; -0.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cetaphil® Restoraderm (Other); Excipial (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- PD Dr. Jan Kottner
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Overall Dry Skin Score (ODS) |
-0.9; -1.2; -0.9 | — |
| SECONDARY Stratum Corneum Hydration (SCH) |
2.8; 1.6; 2.0 | — |
| SECONDARY Transepidermal Water Loss (TEWL) |
1.8; 1.4; 3.4 | — |
| SECONDARY Skin Surface pH |
0.07; 0.3; 0.1 | — |
| SECONDARY 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 |
1.3; 1.0; 1.0 | — |
| SECONDARY Number of Participants With a Pressure Ulcer at Baseline |
2; 7; 3 | — |
| SECONDARY Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline |
16; 19; 12 | — |
| SECONDARY Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline |
6.1; 7.1; 6.2 | — |
| SECONDARY Quality of Life Sum Score at Baseline |
16.42; 18.33; 11.09 | — |
| SECONDARY Number of Participants With Pressure Ulcer at Day 28 +/-3 |
1; 3; 0 | — |
| SECONDARY Number of Participants With Pressure Ulcer at Day 56 +/-3 |
2; 3; 0 | — |
| SECONDARY Number of Participants With Skin Tears at Baseline |
2; 1; 5 | — |
| SECONDARY Number of Participants With Skin Tears at Day 28 +/-3 |
1; 1; 4 | — |
| SECONDARY Number of Participants With Skin Tears at Day 56 +/-3 |
2; 0; 3 | — |
| SECONDARY Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3 |
20; 18; 21 | — |
| SECONDARY Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3 |
8; 13; 9 | — |
| SECONDARY Quality of Life Sum Score at Day 56 +/-3 |
17.55; 19.00; 14.00 | — |
| SECONDARY Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline |
6.8; 7.2; 6.5 | — |
| SECONDARY Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline |
7.6; 8.4; 7.0 | — |
| SECONDARY Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline |
7.1; 8.4; 7.8 | — |
| SECONDARY Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline |
7.1; 7.5; 7.0 | — |
| SECONDARY Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3 |
7.1; 7.9; 7.4 | — |
| SECONDARY Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3 |
7.9; 7.1; 8.0 | — |
| SECONDARY Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3 |
6.9; 7.5; 7.1 | — |
| SECONDARY Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3 |
6.6; 9.3; 7.8 | — |
| SECONDARY Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3 |
7.3; 8.1; 7.7 | — |
| SECONDARY Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline |
1.6; 2.0; 1.9 | — |
| SECONDARY 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 |
3.0; 4.0; 3.3 | — |
| SECONDARY Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline |
1.2; 1.2; 1.4 | — |
| SECONDARY 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 |
1.1; 1.4; 1.6 | — |
| SECONDARY 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 |
1.0; 1.1; 1.0 | — |
| SECONDARY Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3 |
1.7; 1.8; 1.9 | — |
| SECONDARY 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 |
2.8; 2.9; 3.3 | — |
| SECONDARY Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3 |
1.2; 1.0; 1.2 | — |
| SECONDARY 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 |
1.2; 1.1; 1.3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02216526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.