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Completed

NCT Number: NCT02557698

Effectiveness of Using an Oil 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.

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Key information

Conditions

Xerosis Cutis

Age range

6 month–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balneum oil bath

Other

Primary outcomes

  1. Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm

    Time frame: 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 outcomes

  1. Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm

    Time frame: 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

  2. Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg

    Time frame: 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)

  3. Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg

    Time frame: 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)

  4. Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg

    Time frame: 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)

  5. Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg

    Time frame: 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)

  6. Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg

    Time frame: 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

  7. Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg

    Time frame: 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

  8. Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg

    Time frame: 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.

  9. Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg

    Time frame: 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.

  10. Skin Surface pH at the Right Lateral Lower Leg

    Time frame: 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.

  11. Skin Surface pH at the Right Lateral Lower Leg

    Time frame: 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.

  12. Overall Dry Skin (ODS) Score at the Left Arm

    Time frame: 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

  13. Overall Dry Skin (ODS) Score at the Left Arm

    Time frame: 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)

  14. Overall Dry Skin (ODS) Score at the Right Arm

    Time frame: 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)

  15. Overall Dry Skin (ODS) Score at the Right Arm

    Time frame: 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)

  16. Overall Dry Skin (ODS) Score at the Left Lower Leg

    Time frame: 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

  17. Overall Dry Skin (ODS) Score at the Left Lower Leg

    Time frame: 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

  18. Overall Dry Skin (ODS) Score at the Right Lower Leg

    Time frame: 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

  19. Overall Dry Skin (ODS) Score at the Right Lower Leg

    Time frame: 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)

  20. Overall Dry Skin (ODS) Score at the Trunk

    Time frame: 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)

  21. Overall Dry Skin (ODS) Score at the Trunk

    Time frame: 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

  22. Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm

    Time frame: 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)

  23. Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm

    Time frame: 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)

  24. Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm

    Time frame: 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

  25. Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm

    Time frame: 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

  26. Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm

    Time frame: 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.

  27. Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm

    Time frame: 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.

  28. Skin Surface pH at the Left Midvolar Forearm

    Time frame: 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.

  29. Skin Surface pH at the Left Midvolar Forearm

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2015
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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