Effectiveness of Using an Oil Bath Additive

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

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.

Study Overview

• Status: Completed
• Conditions: Xerosis Cutis
• Intervention / Treatment: Other: Balneum oil bath

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite - Universitatsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 85 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 21, 2015
• First Submitted That Met QC Criteria: September 22, 2015
• First Posted (Estimate): September 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CRC-SP-ABC-13