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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02216526
Date of registration:	11/08/2014
Prospective Registration:	Yes
Primary sponsor:	PD Dr. Jan Kottner
Public title:	Skin Health and Effectiveness of Standardized Skin Care Regimens in Nursing Home Residents
Scientific title:	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
Date of first enrolment:	September 2014
Target sample size:	133
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02216526
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
Phase:	N/A

Countries of recruitment
Germany

Contacts

Name:	Ulrike Blume-Peytavi, Prof. Dr.
Address:
Telephone:
Email:
Affiliation:	Charite University, Berlin, Germany

Key inclusion & exclusion 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.

Age minimum: 65 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Xerosis Cutis

Intervention(s)

Other: Cetaphil® Restoraderm

Other: Excipial

Primary Outcome(s)

Change From Baseline in Overall Dry Skin Score (ODS) [Time Frame: Baseline; Day 56+/-4]

Secondary Outcome(s)

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 [Time Frame: Baseline]

Number of Participants With Pressure Ulcer at Day 56 +/-3 [Time Frame: Day 56 +/-3]

Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline [Time Frame: Baseline]

Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline [Time Frame: 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 [Time Frame: Baseline]

Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3 [Time Frame: Day 28 +/-3]

Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3 [Time Frame: 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 [Time Frame: Day 56 +/-3]

Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline [Time Frame: Baseline]

Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline [Time Frame: Baseline]

Number of Participants With Skin Tears at Baseline [Time Frame: Baseline]

Quality of Life Sum Score at Day 56 +/-3 [Time Frame: Day 56 +/-3]

Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline [Time Frame: Baseline]

Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline [Time Frame: Baseline]

Transepidermal Water Loss (TEWL) [Time Frame: Baseline, Day 56 +/- 4]

Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3 [Time Frame: Day 56 +/-3]

Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3 [Time Frame: Day 56 +/-3]

Number of Participants With Skin Tears at Day 28 +/-3 [Time Frame: Day 28 +/-3]

Quality of Life Sum Score at Baseline [Time Frame: Baseline]

Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline [Time Frame: Baseline]

Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3 [Time Frame: Day 56 +/-3]

Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3 [Time Frame: Day 56 +/-3]

Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3 [Time Frame: Day 56 +/-3]

Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3 [Time Frame: Day 56 +/-3]

Stratum Corneum Hydration (SCH) [Time Frame: Baseline, Day 56 +/- 4]

Number of Participants With a Pressure Ulcer at Baseline [Time Frame: Baseline]

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 [Time Frame: Day 56 +/-3]

Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3 [Time Frame: Day 56 +/-3]

Number of Participants With Pressure Ulcer at Day 28 +/-3 [Time Frame: Day 28 +/-3]

Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline [Time Frame: Baseline]

Skin Surface pH [Time Frame: Baseline, Day 56 +/- 4]

Number of Participants With Skin Tears at Day 56 +/-3 [Time Frame: Day 56 +/-3]

Secondary ID(s)

CRC-SP-A-15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	13/04/2018
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02216526

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