Effectiveness of Using an Oil Bath Additive

Not Applicable

Completed

Conditions: Xerosis Cutis

Interventions: Other: Balneum oil bath

Registration Number: NCT02557698

Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balneum oil bath	Balneum oil bath	Balneum oil bath, bathing every other day for four weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg	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 at the right lateral lower leg. Visit 3 (day 28)
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
Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg	Day 28 +/- 3	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 pH at the Right Lateral Lower Leg	Day 28 +/- 3	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.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg	Day 28 +/- 3	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)
Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg	Day 28 +/- 3	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.
Overall Dry Skin (ODS) Score at the Left Lower Leg	Day 28 +/- 3	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
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm	Day 28 +/- 3	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)
Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm	Day 28 +/- 3	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
Overall Dry Skin (ODS) Score at the Left Arm	Day 28 +/- 3	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)
Overall Dry Skin (ODS) Score at the Right Arm	Day 28 +/- 3	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)
Overall Dry Skin (ODS) Score at the Right Lower Leg	Day 28 +/- 3	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)
Overall Dry Skin (ODS) Score at the Trunk	Day 28 +/- 3	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
Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm	Day 28 +/- 3	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 28 +/- 3	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.