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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balneum oil bath | Experimental | Balneum oil bath, bathing every other day for four weeks |
|
| standard skin cleanser | No Intervention | Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balneum oil bath | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 28 +/- 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27815985 | Derived | Kottner J, Kanti V, Dobos G, Hahnel E, Lichterfeld-Kottner A, Richter C, Hillmann K, Vogt A, Blume-Peytavi U. The effectiveness of using a bath oil to reduce signs of dry skin: A randomized controlled pragmatic study. Int J Nurs Stud. 2017 Jan;65:17-24. doi: 10.1016/j.ijnurstu.2016.10.010. Epub 2016 Oct 26. |
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Recruitmant period: Nov 2014 - Apr 2015, Location: Charité University Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Balneum Oil Bath | Balneum oil bath, bathing every other day for four weeks Balneum oil bath |
| FG001 | Standard Skin Cleanser | Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Balneum Oil Bath | Balneum oil bath, bathing every other day for four weeks Balneum oil bath |
| BG001 | Standard Skin Cleanser | Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Male or female gender, aged between 6 months and 85 years | Posted | Mean | Standard Deviation | g/m2/h | Day 28 +/- 3 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Balneum Oil Bath | Balneum oil bath, bathing every other day for four weeks Balneum oil bath |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jan Kottner | Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergology Charité - Universitätsmedizin Berlin | +49 30 450 518218 | jan.kottner@charite.de |
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| Day 14 +/- 2 |
| 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) | Day 14 +/- 2 |
| 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) | Day 28 +/- 3 |
| 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) | Day 14 +/- 2 |
| 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) | Day 28 +/- 3 |
| 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 | Day 14 +/- 2 |
| 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 | Day 28 +/- 3 |
| 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. | Day 14 +/- 2 |
| 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. | Day 28 +/- 3 |
| 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. | Day 14 +/- 2 |
| 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. | Day 28 +/- 3 |
| 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 | Day 14 +/- 2 |
| 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) | Day 28 +/- 3 |
| 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) | Day 14 +/- 2 |
| 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) | Day 28 +/- 3 |
| 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 | Day 14 +/- 2 |
| 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 | Day 28 +/- 3 |
| 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 | Day 14 +/- 2 |
| 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) | Day 28 +/- 3 |
| 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) | Day 14 +/- 2 |
| 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 | Day 28 +/- 3 |
| 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) | Day 14 +/- 2 |
| 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) | Day 28 +/- 3 |
| 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 | Day 14 +/- 2 |
| 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 | Day 28 +/- 3 |
| 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. | Day 14 +/- 2 |
| 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. | Day 28 +/- 3 |
| 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. | Day 14 +/- 2 |
| 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. | Day 28 +/- 3 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Intervention group: 30 control group: 30 | Count of Participants | Participants |
|
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | g/m2/h | Day 14 +/- 2 |
|
|
|
|
| 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) | Posted | Mean | Standard Deviation | g/m2/h | Day 14 +/- 2 |
|
|
|
|
| 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) | Posted | Mean | Standard Deviation | g/m2/h | Day 28 +/- 3 |
|
|
|
|
| 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) | Posted | Mean | Standard Deviation | Arbitrary Units | Day 14 +/- 2 |
|
|
|
|
| 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) | Posted | Mean | Standard Deviation | Arbitrary Units | Day 28 +/- 3 |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | µm | Day 14 +/- 2 |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | µm | Day 28 +/- 3 |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | µm | Day 14 +/- 2 |
|
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|
|
| 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. | Posted | Mean | Standard Deviation | µm | Day 28 +/- 3 |
|
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| 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. | Posted | Mean | Standard Deviation | non-dimensional | Day 14 +/- 2 |
|
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|
|
| 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. | Posted | Mean | Standard Deviation | non-dimensional | Day 28 +/- 3 |
|
|
|
|
| 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 | ODS score 0-4 | Posted | Count of Participants | Participants | Day 14 +/- 2 |
|
|
|
|
| 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) | Posted | Count of Participants | Participants | Day 28 +/- 3 |
|
|
|
|
| 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) | ODS score 0-4 | Posted | Count of Participants | Participants | Day 14 +/- 2 |
|
|
|
|
| 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) | ODS score 0-4 | Posted | Count of Participants | Participants | Day 28 +/- 3 |
|
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|
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| 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 | ODS score 0-4 | Posted | Count of Participants | Participants | Day 14 +/- 2 |
|
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|
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| 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 | ODS score 0-4 | Posted | Count of Participants | Participants | Day 28 +/- 3 |
|
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| 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 | ODS score 0-4 | Posted | Count of Participants | Participants | Day 14 +/- 2 |
|
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|
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| 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) | ODS score 0-4 | Posted | Count of Participants | Participants | Day 28 +/- 3 |
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| 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) | ODS score 0-4 | Posted | Count of Participants | Participants | Day 14 +/- 2 |
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| 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 | ODS score 0-4 | Posted | Count of Participants | Participants | Day 28 +/- 3 |
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| 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) | Posted | Mean | Standard Deviation | Arbitrary Units | Day 14 +/- 2 |
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| 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) | Posted | Mean | Standard Deviation | Arbitrary Units | Day 28 +/- 3 |
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| 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 | Posted | Mean | Standard Deviation | µm | Day 14 +/- 2 |
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| 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 | Posted | Mean | Standard Deviation | µm | Day 28 +/- 3 |
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| 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. | Posted | Mean | Standard Deviation | µm | Day 14 +/- 2 |
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| 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. | Posted | Mean | Standard Deviation | µm | Day 28 +/- 3 |
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| 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. | Posted | Mean | Standard Deviation | non-dimensional | Day 14 +/- 2 |
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| 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. | Posted | Mean | Standard Deviation | non-dimensional | Day 28 +/- 3 |
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| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Standard Skin Cleanser | Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks | 0 | 30 | 0 | 30 |
Not provided
Not provided
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