Effectiveness of Using an Oil Bath Additive

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized Study on the Skin Functional Parameters to Assess Skin Barrier Improvement After the Use of a Commercially Available Oil Bath Containing 84.75% Soybean Oil Compared to no Bath Additive

Conditions
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Xerosis Cutis

Intervention / Treatment
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* Other: Balneum oil bath


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balneum oil bath<br>Balneum oil bath, bathing every other day for four weeks | Other: Balneum oil bath<br> <br> |
| No Intervention: standard skin cleanser<br>Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |