Xerosis Cutis
Conditions
Brief summary
Epidermis that lacks moisture and/or sebum presents as dry skin, which is often characterized by a pattern of fine lines, scaling and itching. In dry skin, the barrier function may be compromised. Skin care practices to decrease the risk of development of dry skin and/or to improve dry skin condition have barely been investigated. Bathing with bath oils has been shown to increase skin hydration, thus helping to stabilize skin barrier function. Therefore, the aim of this study is to investigate the effect of bathing every other day on the skin barrier. Functional parameters, such as TEWL, stratum corneum hydration (SCH) and skin-pH (pH) were measured to characterize skin barrier function.
Interventions
OTHERBalneum oil bath
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent, or children whose parent(s) or guardian(s) have given their written informed consent for their child's participation in the study * Child specific written informed consent, if over 7 years of age * Subjects with a general good and stable health condition * Subjects with clinically stable medical conditions * Accept to abstain from sunbathing and solarium during the study * Overall Dry Skin score (ODS) of 1 to 2 at arms and lower legs * TEWL \> 12 g/m2/h on the left mid volar forearm
Exclusion criteria
* Any dermatological condition or skin affection which may interfere with the study assessments, e.g. scars * Suffering from porphyria * Suffering from severe photodermatoses according to the judgment of the investigator * Clinically significant, possibly unstable medical conditions such as metastatic tumor * Currently having other malignant or benign tumors of the skin in the investigational area * Any other acute or chronic pathology that may interfere with the study conduct in the investigator's opinion * Known allergy or intolerance to any ingredients of the study product, e.g. propylene glycol * Use of (medical) oil-containing bath additives or other oil-containing cleansers * Current topical or systemic treatment affecting the skin, e.g. diuretics * Treatment of dry and/or inflammatory skin conditions with topical corticosteroids during the 4 weeks before inclusion * Systemic immunosuppressive or immunomodulatory therapy * Topical retinoids applied during the 6 weeks before inclusion * Topical application of immunosuppressive treatment during the 6 weeks before inclusion * Therapeutic UV-Radiation during the 6 weeks before inclusion * Increased UV-exposure during the 6 weeks before inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm | Day 28 +/- 3 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg | Day 14 +/- 2 | 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 at the right lateral lower leg. Visit 2 (day14) |
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg | Day 14 +/- 2 | SCH 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) |
| Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg | Day 14 +/- 2 | Skin 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 |
| Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg | Day 14 +/- 2 | Skin 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. |
| Skin Surface pH at the Right Lateral Lower Leg | Day 14 +/- 2 | Skin 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. |
| Overall Dry Skin (ODS) Score at the Left Arm | Day 14 +/- 2 | 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 |
| Overall Dry Skin (ODS) Score at the Right Arm | Day 14 +/- 2 | 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) |
| Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm | Day 14 +/- 2 | 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 2 (day14) - intermediate visit |
| Overall Dry Skin (ODS) Score at the Right Lower Leg | Day 14 +/- 2 | 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 |
| Overall Dry Skin (ODS) Score at the Trunk | Day 14 +/- 2 | 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) |
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm | Day 14 +/- 2 | SCH 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) |
| Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm | Day 14 +/- 2 | Skin 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 |
| Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm | Day 14 +/- 2 | Skin 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. |
| Skin Surface pH at the Left Midvolar Forearm | Day 14 +/- 2 | Skin 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. |
| Overall Dry Skin (ODS) Score at the Left Lower Leg | Day 14 +/- 2 | 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 |
Countries
Germany
Participant flow
Recruitment details
Recruitmant period: Nov 2014 - Apr 2015, Location: Charité University Hospital
Participants by arm
| Arm | Count |
|---|---|
| Balneum Oil Bath Balneum oil bath, bathing every other day for four weeks
Balneum oil bath | 30 |
| Standard Skin Cleanser Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Balneum Oil Bath | Standard Skin Cleanser | Total |
|---|---|---|---|
| Age, Continuous | 34.0 years | 29.5 years | 32.5 years |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 27 Participants |
| Sex: Female, Male Male | 18 Participants | 15 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm
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
Time frame: Day 28 +/- 3
Population: Male or female gender, aged between 6 months and 85 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm | 10.0 g/m2/h | Standard Deviation 2 |
| Standard Skin Cleanser | Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm | 11.9 g/m2/h | Standard Deviation 2.5 |
Comparison: H0=Intervention and control groups do not differ with respect to the TEWL forearm at visit 3 H1=The TEWL on the forearm at visit 3 differs between the groupsp-value: 0.00295% CI: [-3.1, -0.8]t-test, 2 sided
Secondary
Overall Dry Skin (ODS) Score at the Left Arm
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
Time frame: Day 14 +/- 2
Population: ODS score 0-4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 1 | 19 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 0 | 7 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 2 | 4 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 4 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 3 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 4 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 3 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 0 | 7 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 1 | 19 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 2 | 4 Participants |
p-value: 1Wilcoxon (Mann-Whitney)
Secondary
Overall Dry Skin (ODS) Score at the Left Arm
The 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)
Time frame: Day 28 +/- 3
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 1 | 14 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 3 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 2 | 3 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 4 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 0 | 13 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 4 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 0 | 13 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 1 | 13 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 2 | 4 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Arm | ODS score 3 | 0 Participants |
p-value: 0.914Wilcoxon (Mann-Whitney)
Secondary
Overall Dry Skin (ODS) Score at the Left Lower Leg
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
Time frame: Day 28 +/- 3
Population: ODS score 0-4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 4 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 0 | 2 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 1 | 17 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 2 | 11 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 3 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 3 | 1 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 2 | 11 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 0 | 4 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 4 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 1 | 14 Participants |
p-value: 0.581Wilcoxon (Mann-Whitney)
Secondary
Overall Dry Skin (ODS) Score at the Left Lower Leg
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
Time frame: Day 14 +/- 2
Population: ODS score 0-4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 1 | 17 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 3 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 2 | 9 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 4 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 0 | 4 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 4 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 0 | 2 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 1 | 13 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 2 | 15 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Left Lower Leg | ODS score 3 | 0 Participants |
p-value: 0.259Wilcoxon (Mann-Whitney)
Secondary
Overall Dry Skin (ODS) Score at the Right Arm
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)
Time frame: Day 28 +/- 3
Population: ODS score 0-4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 1 | 14 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 3 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 2 | 4 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 4 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 0 | 12 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 4 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 0 | 9 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 1 | 18 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 2 | 3 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 3 | 0 Participants |
p-value: 0.585Wilcoxon (Mann-Whitney)
Secondary
Overall Dry Skin (ODS) Score at the Right Arm
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)
Time frame: Day 14 +/- 2
Population: ODS score 0-4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 4 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 1 | 18 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 0 | 8 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 2 | 4 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 3 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 2 | 4 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 3 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 4 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 0 | 6 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Arm | ODS score 1 | 20 Participants |
p-value: 0.822Wilcoxon (Mann-Whitney)
Secondary
Overall Dry Skin (ODS) Score at the Right Lower Leg
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
Time frame: Day 14 +/- 2
Population: ODS score 0-4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 1 | 16 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 3 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 2 | 10 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 4 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 0 | 4 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 4 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 0 | 2 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 1 | 11 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 2 | 17 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 3 | 0 Participants |
p-value: 0.182Wilcoxon (Mann-Whitney)
Secondary
Overall Dry Skin (ODS) Score at the Right Lower Leg
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)
Time frame: Day 28 +/- 3
Population: ODS score 0-4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 1 | 16 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 3 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 2 | 11 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 4 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 0 | 3 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 4 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 0 | 3 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 1 | 14 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 2 | 12 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Right Lower Leg | ODS score 3 | 1 Participants |
p-value: 0.759Wilcoxon (Mann-Whitney)
Secondary
Overall Dry Skin (ODS) Score at the Trunk
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)
Time frame: Day 14 +/- 2
Population: ODS score 0-4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Trunk | ODS score 1 | 15 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Trunk | ODS score 3 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Trunk | ODS score 2 | 2 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Trunk | ODS score 4 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Trunk | ODS score 0 | 13 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Trunk | ODS score 4 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Trunk | ODS score 0 | 14 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Trunk | ODS score 1 | 15 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Trunk | ODS score 2 | 1 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Trunk | ODS score 3 | 0 Participants |
p-value: 0.831Wilcoxon (Mann-Whitney)
Secondary
Overall Dry Skin (ODS) Score at the Trunk
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
Time frame: Day 28 +/- 3
Population: ODS score 0-4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Trunk | ODS score 1 | 10 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Trunk | ODS score 3 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Trunk | ODS score 2 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Trunk | ODS score 4 | 0 Participants |
| Balneum Oil Bath | Overall Dry Skin (ODS) Score at the Trunk | ODS score 0 | 19 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Trunk | ODS score 4 | 0 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Trunk | ODS score 0 | 12 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Trunk | ODS score 1 | 16 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Trunk | ODS score 2 | 2 Participants |
| Standard Skin Cleanser | Overall Dry Skin (ODS) Score at the Trunk | ODS score 3 | 0 Participants |
p-value: 0.084Wilcoxon (Mann-Whitney)
Secondary
Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm
Skin 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
Time frame: Day 28 +/- 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm | 17.4 µm | Standard Deviation 4 |
| Standard Skin Cleanser | Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm | 18.2 µm | Standard Deviation 3 |
p-value: 0.36595% CI: [-2.6, 0.9]t-test, 2 sided
Secondary
Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm
Skin 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
Time frame: Day 14 +/- 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm | 16.5 µm | Standard Deviation 2.6 |
| Standard Skin Cleanser | Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm | 17.1 µm | Standard Deviation 2.1 |
p-value: 0.32595% CI: [-1.8, 0.6]t-test, 2 sided
Secondary
Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg
Skin 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
Time frame: Day 28 +/- 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg | 16.7 µm | Standard Deviation 2.9 |
| Standard Skin Cleanser | Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg | 18.4 µm | Standard Deviation 4.1 |
p-value: 0.06695% CI: [-3.5, 0.1]t-test, 2 sided
Secondary
Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg
Skin 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
Time frame: Day 14 +/- 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg | 16.7 µm | Standard Deviation 2.9 |
| Standard Skin Cleanser | Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg | 17.3 µm | Standard Deviation 4 |
p-value: 0.45895% CI: [-2.5, 1.1]t-test, 2 sided
Secondary
Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm
Skin 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.
Time frame: Day 28 +/- 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm | 69.7 µm | Standard Deviation 12.2 |
| Standard Skin Cleanser | Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm | 70.9 µm | Standard Deviation 8.1 |
p-value: 0.66295% CI: [-6.5, 4.2]t-test, 2 sided
Secondary
Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm
Skin 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.
Time frame: Day 14 +/- 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm | 66.7 µm | Standard Deviation 8.3 |
| Standard Skin Cleanser | Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm | 70.4 µm | Standard Deviation 10.6 |
p-value: 0.14395% CI: [-8.5, 1.3]t-test, 2 sided
Secondary
Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg
Skin 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.
Time frame: Day 14 +/- 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg | 70.1 µm | Standard Deviation 11.6 |
| Standard Skin Cleanser | Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg | 75.1 µm | Standard Deviation 18.9 |
p-value: 0.17195% CI: [-13.7, 2.5]t-test, 2 sided
Secondary
Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg
Skin 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.
Time frame: Day 28 +/- 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg | 72.1 µm | Standard Deviation 13 |
| Standard Skin Cleanser | Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg | 79.6 µm | Standard Deviation 16.9 |
p-value: 0.05995% CI: [-15.3, 0.3]t-test, 2 sided
Secondary
Skin Surface pH at the Left Midvolar Forearm
Skin 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.
Time frame: Day 28 +/- 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Skin Surface pH at the Left Midvolar Forearm | 5.2 non-dimensional | Standard Deviation 0.6 |
| Standard Skin Cleanser | Skin Surface pH at the Left Midvolar Forearm | 5.1 non-dimensional | Standard Deviation 0.5 |
p-value: 0.68795% CI: [-0.2, 0.4]t-test, 2 sided
Secondary
Skin Surface pH at the Left Midvolar Forearm
Skin 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.
Time frame: Day 14 +/- 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Skin Surface pH at the Left Midvolar Forearm | 5.1 non-dimensional | Standard Deviation 0.6 |
| Standard Skin Cleanser | Skin Surface pH at the Left Midvolar Forearm | 5.3 non-dimensional | Standard Deviation 0.5 |
p-value: 0.32695% CI: [-0.4, 0.1]t-test, 2 sided
Secondary
Skin Surface pH at the Right Lateral Lower Leg
Skin 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.
Time frame: Day 14 +/- 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Skin Surface pH at the Right Lateral Lower Leg | 5.4 non-dimensional | Standard Deviation 0.7 |
| Standard Skin Cleanser | Skin Surface pH at the Right Lateral Lower Leg | 5.3 non-dimensional | Standard Deviation 0.5 |
p-value: 0.495% CI: [-0.2, 0.5]t-test, 2 sided
Secondary
Skin Surface pH at the Right Lateral Lower Leg
Skin 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.
Time frame: Day 28 +/- 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Skin Surface pH at the Right Lateral Lower Leg | 5.2 non-dimensional | Standard Deviation 0.5 |
| Standard Skin Cleanser | Skin Surface pH at the Right Lateral Lower Leg | 5.1 non-dimensional | Standard Deviation 0.4 |
p-value: 0.195% CI: [-0.1, 0.4]t-test, 2 sided
Secondary
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm
SCH 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)
Time frame: Day 14 +/- 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm | 37.3 Arbitrary Units | Standard Deviation 6 |
| Standard Skin Cleanser | Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm | 33.8 Arbitrary Units | Standard Deviation 8.7 |
p-value: 0.0795% CI: [-0.3, 7.4]t-test, 2 sided
Secondary
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm
SCH 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)
Time frame: Day 28 +/- 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm | 38.2 Arbitrary Units | Standard Deviation 7.4 |
| Standard Skin Cleanser | Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm | 34.1 Arbitrary Units | Standard Deviation 6.7 |
p-value: 0.02995% CI: [0.4, 7.7]t-test, 2 sided
Secondary
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg
SCH 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)
Time frame: Day 14 +/- 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg | 29.9 Arbitrary Units | Standard Deviation 6.7 |
| Standard Skin Cleanser | Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg | 30.0 Arbitrary Units | Standard Deviation 8 |
p-value: 0.96495% CI: [-3.9, 3.7]t-test, 2 sided
Secondary
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg
SCH 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)
Time frame: Day 28 +/- 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg | 32.3 Arbitrary Units | Standard Deviation 7.7 |
| Standard Skin Cleanser | Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg | 28.0 Arbitrary Units | Standard Deviation 7.1 |
p-value: 0.02595% CI: [0.5, 8.2]t-test, 2 sided
Secondary
Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm
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 2 (day14) - intermediate visit
Time frame: Day 14 +/- 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm | 9.7 g/m2/h | Standard Deviation 2.2 |
| Standard Skin Cleanser | Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm | 12.0 g/m2/h | Standard Deviation 2.3 |
p-value: <0.00195% CI: [-3.5, -1.2]t-test, 2 sided
Secondary
Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg
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 at the right lateral lower leg. Visit 3 (day 28)
Time frame: Day 28 +/- 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg | 9.3 g/m2/h | Standard Deviation 2 |
| Standard Skin Cleanser | Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg | 11.0 g/m2/h | Standard Deviation 3.2 |
p-value: 0.01795% CI: [-3.1, -0.3]t-test, 2 sided
Secondary
Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg
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 at the right lateral lower leg. Visit 2 (day14)
Time frame: Day 14 +/- 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balneum Oil Bath | Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg | 9.0 g/m2/h | Standard Deviation 1.9 |
| Standard Skin Cleanser | Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg | 10.7 g/m2/h | Standard Deviation 3.6 |
p-value: 0.02495% CI: [-3.2, -0.2]t-test, 2 sided