Trial Outcomes & Findings for Skin Health and Effectiveness of Standardized Skin Care Regimens in Nursing Home Residents (NCT NCT02216526)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

133 participants

Primary outcome timeframe

Baseline; Day 56+/-4

Results posted on

2018-04-13

Participant Flow

completed, recruitment period: September 2014 to May 2015, nursing homes

Participant milestones

Participant milestones
Measure	Cetaphil® Restoraderm Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care Usual skin care routine of the nursing home resident
Overall Study STARTED	45	44	44
Overall Study COMPLETED	40	41	36
Overall Study NOT COMPLETED	5	3	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Cetaphil® Restoraderm Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care Usual skin care routine of the nursing home resident
Overall Study Adverse Event	1	1	0
Overall Study Death	0	1	3
Overall Study Protocol Violation	2	0	2
Overall Study Hospitalization	2	1	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetaphil® Restoraderm n=45 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=44 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=44 Participants Usual skin care routine of the nursing home resident	Total n=133 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=44 Participants	0 Participants n=133 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=44 Participants	0 Participants n=133 Participants
Age, Categorical >=65 years	45 Participants n=45 Participants	44 Participants n=44 Participants	44 Participants n=44 Participants	133 Participants n=133 Participants
Sex: Female, Male Female	25 Participants n=45 Participants	32 Participants n=44 Participants	30 Participants n=44 Participants	87 Participants n=133 Participants
Sex: Female, Male Male	20 Participants n=45 Participants	12 Participants n=44 Participants	14 Participants n=44 Participants	46 Participants n=133 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Germany	45 participants n=45 Participants	44 participants n=44 Participants	44 participants n=44 Participants	133 participants n=133 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=39 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=41 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=35 Participants Usual skin care routine of the nursing home resident
Change From Baseline in Overall Dry Skin Score (ODS)	-0.9 units on a scale Standard Deviation 1.9	-1.2 units on a scale Standard Deviation 1.1	-0.9 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=39 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=40 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=34 Participants Usual skin care routine of the nursing home resident
Stratum Corneum Hydration (SCH)	2.8 arbitrary units Standard Deviation 8.9	1.6 arbitrary units Standard Deviation 10.1	2.0 arbitrary units Standard Deviation 8.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=36 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=38 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=31 Participants Usual skin care routine of the nursing home resident
Transepidermal Water Loss (TEWL)	1.8 g/m2/h Standard Deviation 11.4	1.4 g/m2/h Standard Deviation 12.3	3.4 g/m2/h Standard Deviation 7.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=39 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=40 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=32 Participants Usual skin care routine of the nursing home resident
Skin Surface pH	0.07 units on a scale Standard Deviation 0.7	0.3 units on a scale Standard Deviation 0.8	0.1 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline

Population: Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 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'.

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=12 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=9 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=11 Participants Usual skin care routine of the nursing home resident
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	1.0 units on a scale Standard Deviation 0.0	1.0 units on a scale Standard Deviation 0.0

SECONDARY outcome

Timeframe: Baseline

Clinical assessment of the presence of a pressure ulcer.

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=45 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=44 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=44 Participants Usual skin care routine of the nursing home resident
Number of Participants With a Pressure Ulcer at Baseline	2 Participants	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline

Clinical assessment of the presence of incontinence associated dermatitis according to the IAD-IT classification

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=45 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=44 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=44 Participants Usual skin care routine of the nursing home resident
Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline	16 Participants	19 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 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.

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=12 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=9 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=11 Participants Usual skin care routine of the nursing home resident
Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline	6.1 units on a scale Standard Deviation 3.9	7.1 units on a scale Standard Deviation 2.9	6.2 units on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Baseline

Population: Only residents being cognitively not impaired were able to answer the questionnaires (At baseline n = 32/133)

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.

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=12 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=9 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=11 Participants Usual skin care routine of the nursing home resident
Quality of Life Sum Score at Baseline	16.42 units on a scale Standard Deviation 4.69	18.33 units on a scale Standard Deviation 4.18	11.09 units on a scale Standard Deviation 7.37

SECONDARY outcome

Timeframe: Day 28 +/-3

Population: After 4 weeks of the study, in total n= 13 participants were loss to follow up.

Clinical assessment of the presence of pressure ulcer.

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=41 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=42 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=37 Participants Usual skin care routine of the nursing home resident
Number of Participants With Pressure Ulcer at Day 28 +/-3	1 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 56 +/-3

Population: At the end of the study, in total n = 16 participants were loss to follow up.

Clinical assessment of the presence of a pressure ulcer.

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=40 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=41 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=36 Participants Usual skin care routine of the nursing home resident
Number of Participants With Pressure Ulcer at Day 56 +/-3	2 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline

Clinical assessment of the presence of skin tears according to the STAR Classification

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=45 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=44 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=44 Participants Usual skin care routine of the nursing home resident
Number of Participants With Skin Tears at Baseline	2 Participants	1 Participants	5 Participants

SECONDARY outcome

Timeframe: Day 28 +/-3

Population: In total n = 13 participants were loss to follow up after 4 weeks.

Clinical assessment aof the presence of skin tears according to the STAR Classification

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=41 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=42 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=37 Participants Usual skin care routine of the nursing home resident
Number of Participants With Skin Tears at Day 28 +/-3	1 Participants	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 56 +/-3

Population: In total n = 16 participants were loss to follow up after eight weeks (end of the study).

Clinical assessment aof the presence of skin tears according to the STAR Classification

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=40 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=41 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=36 Participants Usual skin care routine of the nursing home resident
Number of Participants With Skin Tears at Day 56 +/-3	2 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 28 +/-3

Population: In total n = 13 participants were loss to follow up after 4 weeks.

Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=41 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=42 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=47 Participants Usual skin care routine of the nursing home resident
Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3	20 Participants	18 Participants	21 Participants

SECONDARY outcome

Timeframe: Day 56 +/-3

Population: In total n = 16 participants were loss to follow up after eight weeks (end of the study).

Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=40 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=41 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=36 Participants Usual skin care routine of the nursing home resident
Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3	8 Participants	13 Participants	9 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=11 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=8 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=9 Participants Usual skin care routine of the nursing home resident
Quality of Life Sum Score at Day 56 +/-3	17.55 units on a scale Standard Deviation 5.22	19.00 units on a scale Standard Deviation 5.76	14.00 units on a scale Standard Deviation 5.52

SECONDARY outcome

Timeframe: Baseline

Population: Only residents being not cognitively impaired were able to answer the questionnaires (in total n = 32/133).

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.

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=12 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=9 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=11 Participants Usual skin care routine of the nursing home resident
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	7.2 units on a scale Standard Deviation 3.4	6.5 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline

Population: Only residents being not cognitively impaired were able to answer the questionnaires (in total n = 32/133 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.

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=12 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=9 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=11 Participants Usual skin care routine of the nursing home resident
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	8.4 units on a scale Standard Deviation 2.1	7.0 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Baseline

Population: Only residents being not cognitively impaired were able to answer the questionnaires (in total 32/133 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.

Outcome measures

Outcome measures
Measure	Cetaphil® Restoraderm n=12 Participants Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks Cetaphil® Restoraderm	Excipial n=9 Participants Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks Excipial	Standard Skin Care n=11 Participants Usual skin care routine of the nursing home resident
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	8.4 units on a scale Standard Deviation 2.3	7.8 units on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: Baseline

Population: Only residents not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 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.