Xerosis CutisNCT02216526
Skin Health and Effectiveness of Standardized Skin Care Regimens in Nursing Home Residents
A study testing Cetaphil® Restoraderm and Excipial in people with Xerosis Cutis, run by PD Dr. Jan Kottner at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Xerosis Cutis
- What is being tested?
- Cetaphil® Restoraderm and Excipial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- "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.
Who cannot join
- "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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Cetaphil® Restoraderm, Excipial
- Keywords
- Skin health, Nursing, Long-term care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetaphil® RestoradermOther
ExcipialOther
| Study group | Role | What they receive |
|---|---|---|
| Cetaphil® Restoraderm | Experimental | Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Receives: 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 Receives: Other: Excipial |
| Standard skin care | No intervention | Usual skin care routine of the nursing home resident |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; Day 56+/-4
Secondary outcomes (34)
Stratum Corneum Hydration (SCH)
Change in Stratum corneum hydration (SCH) at the lower leg. Instrumental skin measurements were conducted to characterize possible effects of the interventions in terms of skin function. The stratum corneum hydration was measured using the Corneometer CM 825 (Courage + Khazaka, Cologne, Germany). This measurement is based on the differences of the dielectric constant of water and other substances. With this device, only the moisture content in the stratum corneum is measured. The arbitrary units (a.u.) range from 0 to 120 where as higher readings indicate higher stratum corneum hydration.Values > 40 a.u. are often considered 'normal', whereas values < 40 a.u. are regarded as typical for dry Skin.
Measured: Baseline, Day 56 +/- 4
Transepidermal Water Loss (TEWL)
Change in Transepidermal water loss (TEWL) at the lower leg. Transepidermal water loss was measured with the Tewameter TM 300 (Courage + Khazaka, Cologne, Germany). The probe captures the constant permeation of water through the stratum corneum in gram per hour per m2. The measuring probe contains a pair of sensors that are located in different distances to the skin surface to determine temperature and relative humidity above the skin surface. The humidity gradient between both sensors is used for calculating the transepidermal water loss. Higher values indicate a higher transepidermal water loss.
Measured: Baseline, Day 56 +/- 4
Skin Surface pH
Changes in Skin surface pH at the lower leg. Skin surface pH was measured with the Skin-pH-Meter PH 905 (Courage + Khazaka, Cologne, Germany), a planar glass electrode. The pH is a measure of acidity and alkalinity of a solution and it indicates the concentration of the hydrogen ions in an aqueous solution. Reference values of human skin have been reported to range from 4 to 6.
Measured: 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
Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
Measured: Baseline
Number of Participants With a Pressure Ulcer at Baseline
Clinical assessment of the presence of a pressure ulcer.
Measured: Baseline
Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline
Clinical assessment of the presence of incontinence associated dermatitis according to the IAD-IT classification
Measured: Baseline
Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline
Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
Measured: Baseline
Quality of Life Sum Score at Baseline
Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from '5' (all the time) to '0' (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. 'In the last two weeks … I was happy' or '…I was relaxed'. The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of < 13 is recommended. The validity and reliability of the questionnaire was recently supported.
Measured: Baseline
Number of Participants With Pressure Ulcer at Day 28 +/-3
Clinical assessment of the presence of pressure ulcer.
Measured: Day 28 +/-3
Number of Participants With Pressure Ulcer at Day 56 +/-3
Clinical assessment of the presence of a pressure ulcer.
Measured: Day 56 +/-3
Number of Participants With Skin Tears at Baseline
Clinical assessment of the presence of skin tears according to the STAR Classification
Measured: Baseline
Number of Participants With Skin Tears at Day 28 +/-3
Clinical assessment aof the presence of skin tears according to the STAR Classification
Measured: Day 28 +/-3
Number of Participants With Skin Tears at Day 56 +/-3
Clinical assessment aof the presence of skin tears according to the STAR Classification
Measured: Day 56 +/-3
Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3
Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification
Measured: Day 28 +/-3
Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3
Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification
Measured: Day 56 +/-3
Quality of Life Sum Score at Day 56 +/-3
Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from '5' (all the time) to '0' (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. 'In the last two weeks … I was happy' or '…I was relaxed'. The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of < 13 is recommended. The validity and reliability of the questionnaire was recently supported.
Measured: Day 56 +/-3
Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline
Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
Measured: Baseline
Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline
Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
Measured: Baseline
Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline
Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
Measured: Baseline
Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline
Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
Measured: Baseline
Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3
Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
Measured: Day 56 +/-3
Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3
Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
Measured: Day 56 +/-3
Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3
Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
Measured: Day 56 +/-3
Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3
Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
Measured: Day 56 +/-3
Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3
Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
Measured: Day 56 +/-3
Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline
Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
Measured: 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
Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
Measured: Baseline
Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline
Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night.
Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
Measured: 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
Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
Measured: 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
Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
Measured: Day 56 +/-3
Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3
Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
Measured: 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
Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
Measured: Day 56 +/-3
Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3
Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night.
Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
Measured: 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
Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
Measured: Day 56 +/-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Xerosis CutisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- PD Dr. Jan Kottner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, PD Dr. Jan Kottner, Charite University, Berlin, Germany
- Investigators
- Ulrike Blume-Peytavi, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216526
- Sponsor's protocol ID
- CRC-SP-A-15
- Status last verified
- Apr 2018
- First submitted
- 11 Aug 2014
- Last updated
- 13 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30987588Hahnel 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.
PubMed 29132305Hahnel 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.
PubMed 28947467Hahnel 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.
PubMed 28214613Kottner 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.
PubMed 25443420
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02216526
- Acronym / sponsor ID
- CRC-SP-A-15
- Conditions
- Xerosis Cutis
- Keywords
- Skin health, Nursing, Long-term care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- PD Dr. Jan KottnerUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Posted 13 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cetaphil® Restoraderm | Experimental | Other: Cetaphil® RestoradermCetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks |
| Excipial | Experimental | Other: ExcipialExcipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks |
| Standard skin care | No intervention | –Usual skin care routine of the nursing home resident |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- "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"
Key exclusion criteria (8 listed)
- "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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetaphil® Restoraderm | Other | Cetaphil® Restoraderm |
| Excipial | Other | Excipial |
Primary outcome
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.
34 secondary outcomes
Stratum Corneum Hydration (SCH)
Time frame: Baseline, Day 56 +/- 4
Transepidermal Water Loss (TEWL)
Time frame: Baseline, Day 56 +/- 4
Skin Surface pH
Time frame: 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
Time frame: Baseline
Number of Participants With a Pressure Ulcer at Baseline
Time frame: Baseline
Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline
Time frame: Baseline
Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline
Time frame: Baseline
Quality of Life Sum Score at Baseline
Time frame: Baseline
Number of Participants With Pressure Ulcer at Day 28 +/-3
Time frame: Day 28 +/-3
Number of Participants With Pressure Ulcer at Day 56 +/-3
Time frame: Day 56 +/-3
Number of Participants With Skin Tears at Baseline
Time frame: Baseline
Number of Participants With Skin Tears at Day 28 +/-3
Time frame: Day 28 +/-3
Number of Participants With Skin Tears at Day 56 +/-3
Time frame: Day 56 +/-3
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
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 3. Awake All Night (0) - Awake Very Little (10) at Baseline
Time frame: Baseline
Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline
Time frame: Baseline
Quality of Sleep. Question 5. Bad Sleep (0) - Good 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 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
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 5. Bad Sleep (0) - Good Sleep (10) 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 Baseline
Time frame: 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
Time frame: Baseline
Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) 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
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
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 Details in the Outcome Measure Description) at Day 56 +/-3
Time frame: 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
Time frame: Day 56 +/-3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30987588Gabriel 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.
- Derived from this study: PubMed 29132305Hahnel 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.
- Derived from this study: PubMed 28947467Hahnel 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.
- Derived from this study: PubMed 28214613Hahnel 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.
- Derived from this study: PubMed 25443420Kottner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Blume-Peytavi, Prof. Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cetaphil® Restoraderm and Excipial in people with Xerosis Cutis, run by PD Dr. Jan Kottner at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Overall Dry Skin Score (ODS) (time frame: Baseline; Day 56+/-4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02216526, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.