Trial Outcomes & Findings for Effectiveness of Using an Oil Bath Additive (NCT NCT02557698)
NCT ID: NCT02557698
Last Updated: 2017-04-05
Results Overview
TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h on the left midvolar forearm. Visit 3 (day 28) - end of study visit
COMPLETED
NA
60 participants
Day 28 +/- 3
2017-04-05
Participant Flow
Recruitmant period: Nov 2014 - Apr 2015, Location: Charité University Hospital
Participant milestones
| Measure |
Balneum Oil Bath
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intervention group: 30 control group: 30
Baseline characteristics by cohort
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.0 years
n=99 Participants
|
29.5 years
n=107 Participants
|
32.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants • Intervention group: 30 control group: 30
|
15 Participants
n=107 Participants • Intervention group: 30 control group: 30
|
27 Participants
n=206 Participants • Intervention group: 30 control group: 30
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants • Intervention group: 30 control group: 30
|
15 Participants
n=107 Participants • Intervention group: 30 control group: 30
|
33 Participants
n=206 Participants • Intervention group: 30 control group: 30
|
PRIMARY outcome
Timeframe: Day 28 +/- 3Population: Male or female gender, aged between 6 months and 85 years
TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h on the left midvolar forearm. Visit 3 (day 28) - end of study visit
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm
|
10.0 g/m2/h
Standard Deviation 2.0
|
11.9 g/m2/h
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Day 14 +/- 2TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h on the left midvolar forearm. Visit 2 (day14) - intermediate visit
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm
|
9.7 g/m2/h
Standard Deviation 2.2
|
12.0 g/m2/h
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Day 14 +/- 2TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h at the right lateral lower leg. Visit 2 (day14)
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg
|
9.0 g/m2/h
Standard Deviation 1.9
|
10.7 g/m2/h
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Day 28 +/- 3TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h at the right lateral lower leg. Visit 3 (day 28)
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg
|
9.3 g/m2/h
Standard Deviation 2
|
11.0 g/m2/h
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Day 14 +/- 2SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out. Visit 2 (day 14)
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg
|
29.9 Arbitrary Units
Standard Deviation 6.7
|
30.0 Arbitrary Units
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Day 28 +/- 3SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher is SCH. Per investigational site three replicate measurements were carried out. Visit 3 (day 28)
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg
|
32.3 Arbitrary Units
Standard Deviation 7.7
|
28.0 Arbitrary Units
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: Day 14 +/- 2Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg
|
16.7 µm
Standard Deviation 2.9
|
17.3 µm
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Day 28 +/- 3Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg
|
16.7 µm
Standard Deviation 2.9
|
18.4 µm
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Day 14 +/- 2Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg
|
70.1 µm
Standard Deviation 11.6
|
75.1 µm
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: Day 28 +/- 3Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg
|
72.1 µm
Standard Deviation 13.0
|
79.6 µm
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: Day 14 +/- 2Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH of the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Skin Surface pH at the Right Lateral Lower Leg
|
5.4 non-dimensional
Standard Deviation 0.7
|
5.3 non-dimensional
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Day 28 +/- 3Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH of the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Skin Surface pH at the Right Lateral Lower Leg
|
5.2 non-dimensional
Standard Deviation 0.5
|
5.1 non-dimensional
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Day 14 +/- 2Population: ODS score 0-4
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk. (0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day14) - intermediate visit
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Overall Dry Skin (ODS) Score at the Left Arm
ODS score 0
|
7 Participants
|
7 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Arm
ODS score 1
|
19 Participants
|
19 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Arm
ODS score 2
|
4 Participants
|
4 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Arm
ODS score 3
|
0 Participants
|
0 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Arm
ODS score 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28 +/- 3The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness by the investigator using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk. (0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks)
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Overall Dry Skin (ODS) Score at the Left Arm
ODS score 0
|
13 Participants
|
13 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Arm
ODS score 1
|
14 Participants
|
13 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Arm
ODS score 2
|
3 Participants
|
4 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Arm
ODS score 3
|
0 Participants
|
0 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Arm
ODS score 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14 +/- 2Population: ODS score 0-4
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk. (0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day14)
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Overall Dry Skin (ODS) Score at the Right Arm
ODS score 0
|
8 Participants
|
6 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Arm
ODS score 1
|
18 Participants
|
20 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Arm
ODS score 2
|
4 Participants
|
4 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Arm
ODS score 3
|
0 Participants
|
0 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Arm
ODS score 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28 +/- 3Population: ODS score 0-4
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk. (0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28)
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Overall Dry Skin (ODS) Score at the Right Arm
ODS score 4
|
0 Participants
|
0 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Arm
ODS score 0
|
12 Participants
|
9 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Arm
ODS score 1
|
14 Participants
|
18 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Arm
ODS score 2
|
4 Participants
|
3 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Arm
ODS score 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14 +/- 2Population: ODS score 0-4
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk. (0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14) - intermediate visit
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Overall Dry Skin (ODS) Score at the Left Lower Leg
ODS score 0
|
4 Participants
|
2 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Lower Leg
ODS score 1
|
17 Participants
|
13 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Lower Leg
ODS score 2
|
9 Participants
|
15 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Lower Leg
ODS score 3
|
0 Participants
|
0 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Lower Leg
ODS score 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28 +/- 3Population: ODS score 0-4
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk. (0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28) - end of study visit
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Overall Dry Skin (ODS) Score at the Left Lower Leg
ODS score 0
|
2 Participants
|
4 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Lower Leg
ODS score 1
|
17 Participants
|
14 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Lower Leg
ODS score 2
|
11 Participants
|
11 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Lower Leg
ODS score 3
|
0 Participants
|
1 Participants
|
|
Overall Dry Skin (ODS) Score at the Left Lower Leg
ODS score 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14 +/- 2Population: ODS score 0-4
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk. (0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14) - intermediate visit
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Overall Dry Skin (ODS) Score at the Right Lower Leg
ODS score 0
|
4 Participants
|
2 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Lower Leg
ODS score 1
|
16 Participants
|
11 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Lower Leg
ODS score 2
|
10 Participants
|
17 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Lower Leg
ODS score 3
|
0 Participants
|
0 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Lower Leg
ODS score 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28 +/- 3Population: ODS score 0-4
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk. (0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28)
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Overall Dry Skin (ODS) Score at the Right Lower Leg
ODS score 0
|
3 Participants
|
3 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Lower Leg
ODS score 1
|
16 Participants
|
14 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Lower Leg
ODS score 2
|
11 Participants
|
12 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Lower Leg
ODS score 3
|
0 Participants
|
1 Participants
|
|
Overall Dry Skin (ODS) Score at the Right Lower Leg
ODS score 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14 +/- 2Population: ODS score 0-4
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk. (0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14)
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Overall Dry Skin (ODS) Score at the Trunk
ODS score 0
|
13 Participants
|
14 Participants
|
|
Overall Dry Skin (ODS) Score at the Trunk
ODS score 1
|
15 Participants
|
15 Participants
|
|
Overall Dry Skin (ODS) Score at the Trunk
ODS score 2
|
2 Participants
|
1 Participants
|
|
Overall Dry Skin (ODS) Score at the Trunk
ODS score 3
|
0 Participants
|
0 Participants
|
|
Overall Dry Skin (ODS) Score at the Trunk
ODS score 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28 +/- 3Population: ODS score 0-4
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk. (0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28) - end of study visit
Outcome measures
| Measure |
Balneum Oil Bath
n=29 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Overall Dry Skin (ODS) Score at the Trunk
ODS score 0
|
19 Participants
|
12 Participants
|
|
Overall Dry Skin (ODS) Score at the Trunk
ODS score 1
|
10 Participants
|
16 Participants
|
|
Overall Dry Skin (ODS) Score at the Trunk
ODS score 2
|
0 Participants
|
2 Participants
|
|
Overall Dry Skin (ODS) Score at the Trunk
ODS score 3
|
0 Participants
|
0 Participants
|
|
Overall Dry Skin (ODS) Score at the Trunk
ODS score 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14 +/- 2SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out. Visit 2 (day 14)
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm
|
37.3 Arbitrary Units
Standard Deviation 6.0
|
33.8 Arbitrary Units
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Day 28 +/- 3SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out. Visit 3 (day 28)
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm
|
38.2 Arbitrary Units
Standard Deviation 7.4
|
34.1 Arbitrary Units
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Day 14 +/- 2Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm
|
16.5 µm
Standard Deviation 2.6
|
17.1 µm
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Day 28 +/- 3Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm
|
17.4 µm
Standard Deviation 4.0
|
18.2 µm
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Day 14 +/- 2Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm
|
66.7 µm
Standard Deviation 8.3
|
70.4 µm
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Day 28 +/- 3Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm
|
69.7 µm
Standard Deviation 12.2
|
70.9 µm
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Day 14 +/- 2Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH on the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Skin Surface pH at the Left Midvolar Forearm
|
5.1 non-dimensional
Standard Deviation 0.6
|
5.3 non-dimensional
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Day 28 +/- 3Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH on the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.
Outcome measures
| Measure |
Balneum Oil Bath
n=30 Participants
Balneum oil bath, bathing every other day for four weeks
Balneum oil bath
|
Standard Skin Cleanser
n=30 Participants
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
|
|---|---|---|
|
Skin Surface pH at the Left Midvolar Forearm
|
5.2 non-dimensional
Standard Deviation 0.6
|
5.1 non-dimensional
Standard Deviation 0.5
|
Adverse Events
Balneum Oil Bath
Standard Skin Cleanser
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jan Kottner
Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergology Charité - Universitätsmedizin Berlin
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place