Xerosis Cutis
Conditions
Keywords
Skin health, Nursing, Long-term care
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.
Interventions
OTHERCetaphil® Restoraderm
OTHERExcipial
Sponsors
PD Dr. Jan Kottner
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Overall Dry Skin Score (ODS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Transepidermal Water Loss (TEWL) | Baseline, Day 56 +/- 4 | 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. |
| Skin Surface pH | Baseline, Day 56 +/- 4 | 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. |
| 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 | 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'. |
| Number of Participants With a Pressure Ulcer at Baseline | Baseline | Clinical assessment of the presence of a pressure ulcer. |
| Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline | Baseline | Clinical assessment of the presence of incontinence associated dermatitis according to the IAD-IT classification |
| Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline | 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. |
| Quality of Life Sum Score at Baseline | 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. |
| Number of Participants With Pressure Ulcer at Day 28 +/-3 | Day 28 +/-3 | Clinical assessment of the presence of pressure ulcer. |
| Number of Participants With Pressure Ulcer at Day 56 +/-3 | Day 56 +/-3 | Clinical assessment of the presence of a pressure ulcer. |
| Number of Participants With Skin Tears at Baseline | Baseline | Clinical assessment of the presence of skin tears according to the STAR Classification |
| Number of Participants With Skin Tears at Day 28 +/-3 | Day 28 +/-3 | Clinical assessment aof the presence of skin tears according to the STAR Classification |
| Number of Participants With Skin Tears at Day 56 +/-3 | Day 56 +/-3 | Clinical assessment aof the presence of skin tears according to the STAR Classification |
| Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3 | Day 28 +/-3 | Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification |
| Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3 | Day 56 +/-3 | Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification |
| Quality of Life Sum Score at Day 56 +/-3 | 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. |
| Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline | 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. |
| Stratum Corneum Hydration (SCH) | Baseline, Day 56 +/- 4 | 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. |
| Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline | 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. |
| Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline | 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. |
| Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3 | 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. |
| Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3 | 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. |
| Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3 | 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. |
| Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3 | 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. |
| Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3 | 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. |
| Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline | 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'. |
| 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 | 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'. |
| Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline | 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'. |
| 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 | 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'. |
| 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 | 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'. |
| Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3 | 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'. |
| 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 | 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'. |
| Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3 | 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'. |
| 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 | 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'. |
| Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline | 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. |
Countries
Germany
Participant flow
Recruitment details
completed, recruitment period: September 2014 to May 2015, nursing homes
Participants by arm
| Arm | Count |
|---|---|
| Cetaphil® Restoraderm Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks
Cetaphil® Restoraderm | 45 |
| Excipial Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks
Excipial | 44 |
| Standard Skin Care Usual skin care routine of the nursing home resident | 44 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 |
| Overall Study | Death | 0 | 1 | 3 |
| Overall Study | Hospitalization | 2 | 1 | 3 |
| Overall Study | Protocol Violation | 2 | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Excipial | Standard Skin Care | Cetaphil® Restoraderm |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 133 Participants | 44 Participants | 44 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment Germany | 133 participants | 44 participants | 44 participants | 45 participants |
| Sex: Female, Male Female | 87 Participants | 32 Participants | 30 Participants | 25 Participants |
| Sex: Female, Male Male | 46 Participants | 12 Participants | 14 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 45 | 1 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 45 | 0 / 44 | 0 / 44 |
Outcome results
Primary
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.
Time frame: Baseline; Day 56+/-4
Population: At Day 56 +/- 3 data of two participants to calculate the Change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group III (Standard Skin care) 35/36 participants were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Change From Baseline in Overall Dry Skin Score (ODS) | -0.9 units on a scale | Standard Deviation 1.9 |
| Excipial | Change From Baseline in Overall Dry Skin Score (ODS) | -1.2 units on a scale | Standard Deviation 1.1 |
| Standard Skin Care | Change From Baseline in Overall Dry Skin Score (ODS) | -0.9 units on a scale | Standard Deviation 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
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'.
Time frame: Baseline
Population: Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | 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 units on a scale | Standard Deviation 1.1 |
| Excipial | 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 | 1.0 units on a scale | Standard Deviation 0 |
| Standard Skin Care | 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 | 1.0 units on a scale | Standard Deviation 0 |
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
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'.
Time frame: Day 56 +/-3
Population: Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question. In the Excipial Group one value is missing for that question.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | 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 units on a scale | Standard Deviation 0 |
| Excipial | 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 | 1.1 units on a scale | Standard Deviation 0.4 |
| Standard Skin Care | 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 units on a scale | Standard Deviation 0 |
Secondary
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'.
Time frame: Baseline
Population: Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline | 1.6 units on a scale | Standard Deviation 0.7 |
| Excipial | Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline | 2.0 units on a scale | Standard Deviation 1 |
| Standard Skin Care | Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline | 1.9 units on a scale | Standard Deviation 0.9 |
Secondary
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'.
Time frame: Day 56 +/-3
Population: Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3 | 1.7 units on a scale | Standard Deviation 1 |
| Excipial | Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3 | 1.8 units on a scale | Standard Deviation 0.7 |
| Standard Skin Care | Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3 | 1.9 units on a scale | Standard Deviation 0.9 |
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
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'.
Time frame: Baseline
Population: Only participants not being cognitively impaired were able to answer the quastionnaires (in total n = 32/133 at baseline). One value in the Excipial Group is missing for this question.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | 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 units on a scale | Standard Deviation 1.5 |
| Excipial | 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 | 4.0 units on a scale | Standard Deviation 0 |
| Standard Skin Care | 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 | 3.3 units on a scale | Standard Deviation 1.3 |
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
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'.
Time frame: Day 56 +/-3
Population: Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | 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 units on a scale | Standard Deviation 1.8 |
| Excipial | 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 | 2.9 units on a scale | Standard Deviation 1.6 |
| Standard Skin Care | 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 | 3.3 units on a scale | Standard Deviation 1.6 |
Secondary
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'.
Time frame: Day 56 +/-3
Population: Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3 | 1.2 units on a scale | Standard Deviation 0.4 |
| Excipial | Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3 | 1.0 units on a scale | Standard Deviation 0 |
| Standard Skin Care | Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3 | 1.2 units on a scale | Standard Deviation 0.4 |
Secondary
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'.
Time frame: Baseline
Population: Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline | 1.2 units on a scale | Standard Deviation 0.6 |
| Excipial | Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline | 1.2 units on a scale | Standard Deviation 0.7 |
| Standard Skin Care | Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline | 1.4 units on a scale | Standard Deviation 0.5 |
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
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'.
Time frame: Baseline
Population: Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline). One value in the Cetaphil Group is missing for this question.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | 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 units on a scale | Standard Deviation 0.3 |
| Excipial | 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 | 1.4 units on a scale | Standard Deviation 0.7 |
| Standard Skin Care | 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 | 1.6 units on a scale | Standard Deviation 0.7 |
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
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'.
Time frame: Day 56 +/-3
Population: Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question. In the Cetaphil Group one value is missing for that question.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | 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 units on a scale | Standard Deviation 0.4 |
| Excipial | 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 | 1.1 units on a scale | Standard Deviation 0.4 |
| Standard Skin Care | 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 | 1.3 units on a scale | Standard Deviation 0.5 |
Secondary
Number of Participants With a Pressure Ulcer at Baseline
Clinical assessment of the presence of a pressure ulcer.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cetaphil® Restoraderm | Number of Participants With a Pressure Ulcer at Baseline | 2 Participants |
| Excipial | Number of Participants With a Pressure Ulcer at Baseline | 7 Participants |
| Standard Skin Care | Number of Participants With a Pressure Ulcer at Baseline | 3 Participants |
Secondary
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
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cetaphil® Restoraderm | Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline | 16 Participants |
| Excipial | Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline | 19 Participants |
| Standard Skin Care | Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline | 12 Participants |
Secondary
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
Time frame: Day 28 +/-3
Population: In total n = 13 participants were loss to follow up after 4 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cetaphil® Restoraderm | Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3 | 20 Participants |
| Excipial | Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3 | 18 Participants |
| Standard Skin Care | Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3 | 21 Participants |
Secondary
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
Time frame: Day 56 +/-3
Population: In total n = 16 participants were loss to follow up after eight weeks (end of the study).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cetaphil® Restoraderm | Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3 | 8 Participants |
| Excipial | Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3 | 13 Participants |
| Standard Skin Care | Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3 | 9 Participants |
Secondary
Number of Participants With Pressure Ulcer at Day 28 +/-3
Clinical assessment of the presence of pressure ulcer.
Time frame: Day 28 +/-3
Population: After 4 weeks of the study, in total n= 13 participants were loss to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cetaphil® Restoraderm | Number of Participants With Pressure Ulcer at Day 28 +/-3 | 1 Participants |
| Excipial | Number of Participants With Pressure Ulcer at Day 28 +/-3 | 3 Participants |
| Standard Skin Care | Number of Participants With Pressure Ulcer at Day 28 +/-3 | 0 Participants |
Secondary
Number of Participants With Pressure Ulcer at Day 56 +/-3
Clinical assessment of the presence of a pressure ulcer.
Time frame: Day 56 +/-3
Population: At the end of the study, in total n = 16 participants were loss to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cetaphil® Restoraderm | Number of Participants With Pressure Ulcer at Day 56 +/-3 | 2 Participants |
| Excipial | Number of Participants With Pressure Ulcer at Day 56 +/-3 | 3 Participants |
| Standard Skin Care | Number of Participants With Pressure Ulcer at Day 56 +/-3 | 0 Participants |
Secondary
Number of Participants With Skin Tears at Baseline
Clinical assessment of the presence of skin tears according to the STAR Classification
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cetaphil® Restoraderm | Number of Participants With Skin Tears at Baseline | 2 Participants |
| Excipial | Number of Participants With Skin Tears at Baseline | 1 Participants |
| Standard Skin Care | Number of Participants With Skin Tears at Baseline | 5 Participants |
Secondary
Number of Participants With Skin Tears at Day 28 +/-3
Clinical assessment aof the presence of skin tears according to the STAR Classification
Time frame: Day 28 +/-3
Population: In total n = 13 participants were loss to follow up after 4 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cetaphil® Restoraderm | Number of Participants With Skin Tears at Day 28 +/-3 | 1 Participants |
| Excipial | Number of Participants With Skin Tears at Day 28 +/-3 | 1 Participants |
| Standard Skin Care | Number of Participants With Skin Tears at Day 28 +/-3 | 4 Participants |
Secondary
Number of Participants With Skin Tears at Day 56 +/-3
Clinical assessment aof the presence of skin tears according to the STAR Classification
Time frame: Day 56 +/-3
Population: In total n = 16 participants were loss to follow up after eight weeks (end of the study).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cetaphil® Restoraderm | Number of Participants With Skin Tears at Day 56 +/-3 | 2 Participants |
| Excipial | Number of Participants With Skin Tears at Day 56 +/-3 | 0 Participants |
| Standard Skin Care | Number of Participants With Skin Tears at Day 56 +/-3 | 3 Participants |
Secondary
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.
Time frame: Baseline
Population: Only residents being cognitively not impaired were able to answer the questionnaires (At baseline n = 32/133)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Quality of Life Sum Score at Baseline | 16.42 units on a scale | Standard Deviation 4.69 |
| Excipial | Quality of Life Sum Score at Baseline | 18.33 units on a scale | Standard Deviation 4.18 |
| Standard Skin Care | Quality of Life Sum Score at Baseline | 11.09 units on a scale | Standard Deviation 7.37 |
Secondary
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.
Time frame: Day 56 +/-3
Population: Only residents being cognitively not impaired were able to answer the questionnaires (in total n = 28/117 at the end of the study).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Quality of Life Sum Score at Day 56 +/-3 | 17.55 units on a scale | Standard Deviation 5.22 |
| Excipial | Quality of Life Sum Score at Day 56 +/-3 | 19.00 units on a scale | Standard Deviation 5.76 |
| Standard Skin Care | Quality of Life Sum Score at Day 56 +/-3 | 14.00 units on a scale | Standard Deviation 5.52 |
Secondary
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.
Time frame: Baseline
Population: Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline | 6.1 units on a scale | Standard Deviation 3.9 |
| Excipial | Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline | 7.1 units on a scale | Standard Deviation 2.9 |
| Standard Skin Care | Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline | 6.2 units on a scale | Standard Deviation 2.9 |
Secondary
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.
Time frame: Day 56 +/-3
Population: Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3 | 7.1 units on a scale | Standard Deviation 2.9 |
| Excipial | Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3 | 7.9 units on a scale | Standard Deviation 2.2 |
| Standard Skin Care | Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3 | 7.4 units on a scale | Standard Deviation 2.8 |
Secondary
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.
Time frame: Baseline
Population: Only residents being not cognitively impaired were able to answer the questionnaires (in total n = 32/133).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline | 6.8 units on a scale | Standard Deviation 3.7 |
| Excipial | Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline | 7.2 units on a scale | Standard Deviation 3.4 |
| Standard Skin Care | Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline | 6.5 units on a scale | Standard Deviation 3.2 |
Secondary
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.
Time frame: Day 56 +/-3
Population: Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3 | 7.9 units on a scale | Standard Deviation 2.9 |
| Excipial | Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3 | 7.1 units on a scale | Standard Deviation 2.8 |
| Standard Skin Care | Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3 | 8.0 units on a scale | Standard Deviation 2.8 |
Secondary
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.
Time frame: Baseline
Population: Only residents being not cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline | 7.6 units on a scale | Standard Deviation 2.6 |
| Excipial | Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline | 8.4 units on a scale | Standard Deviation 2.1 |
| Standard Skin Care | Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline | 7.0 units on a scale | Standard Deviation 2.6 |
Secondary
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.
Time frame: Day 56 +/-3
Population: Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3 | 6.9 units on a scale | Standard Deviation 2.9 |
| Excipial | Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3 | 7.5 units on a scale | Standard Deviation 2.1 |
| Standard Skin Care | Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3 | 7.1 units on a scale | Standard Deviation 2.5 |
Secondary
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.
Time frame: Baseline
Population: Only residents being not cognitively impaired were able to answer the questionnaires (in total 32/133 at baseline).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline | 7.1 units on a scale | Standard Deviation 3.9 |
| Excipial | Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline | 8.4 units on a scale | Standard Deviation 2.3 |
| Standard Skin Care | Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline | 7.8 units on a scale | Standard Deviation 3 |
Secondary
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.
Time frame: Day 56 +/-3
Population: Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3 | 6.6 units on a scale | Standard Deviation 3.4 |
| Excipial | Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3 | 9.3 units on a scale | Standard Deviation 0.6 |
| Standard Skin Care | Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3 | 7.8 units on a scale | Standard Deviation 3.1 |
Secondary
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.
Time frame: Baseline
Population: Only residents not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline | 7.1 units on a scale | Standard Deviation 2.9 |
| Excipial | Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline | 7.5 units on a scale | Standard Deviation 2.8 |
| Standard Skin Care | Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline | 7.0 units on a scale | Standard Deviation 2.9 |
Secondary
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.
Time frame: Day 56 +/-3
Population: Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3 | 7.3 units on a scale | Standard Deviation 3.1 |
| Excipial | Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3 | 8.1 units on a scale | Standard Deviation 2.3 |
| Standard Skin Care | Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3 | 7.7 units on a scale | Standard Deviation 2.8 |
Secondary
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.
Time frame: Baseline, Day 56 +/- 4
Population: At Day 56 +/- 3 data of six participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group II (Excipial) 40/41 participants were analyzed. In Group III (Standard Skin care) 32/36 participants were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Skin Surface pH | 0.07 units on a scale | Standard Deviation 0.7 |
| Excipial | Skin Surface pH | 0.3 units on a scale | Standard Deviation 0.8 |
| Standard Skin Care | Skin Surface pH | 0.1 units on a scale | Standard Deviation 0.7 |
Secondary
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.
Time frame: Baseline, Day 56 +/- 4
Population: At Day 56 +/- 3 data of four participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group II (Excipial) 40/41 participants were analyzed. In Group III (Standard Skin care) 34/36 participants were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Stratum Corneum Hydration (SCH) | 2.8 arbitrary units | Standard Deviation 8.9 |
| Excipial | Stratum Corneum Hydration (SCH) | 1.6 arbitrary units | Standard Deviation 10.1 |
| Standard Skin Care | Stratum Corneum Hydration (SCH) | 2.0 arbitrary units | Standard Deviation 8.9 |
Secondary
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.
Time frame: Baseline, Day 56 +/- 4
Population: At Day 56 +/- 3 data of twelve participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 36/40 participants were analyzed. In Group II (Excipial) 38/41 participants were analyzed. In Group III (Standard Skin care) 31/36 participants were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil® Restoraderm | Transepidermal Water Loss (TEWL) | 1.8 g/m2/h | Standard Deviation 11.4 |
| Excipial | Transepidermal Water Loss (TEWL) | 1.4 g/m2/h | Standard Deviation 12.3 |
| Standard Skin Care | Transepidermal Water Loss (TEWL) | 3.4 g/m2/h | Standard Deviation 7 |