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Effectiveness of Using an Oil Bath Additive

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557698
Recruitment Status : Completed
First Posted : September 23, 2015
Results First Posted : March 7, 2017
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
PD Dr. Jan Kottner, 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.

Condition or disease Intervention/treatment Phase
Xerosis Cutis Other: Balneum oil bath Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : September 2015

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557698


Locations
Layout table for location information
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PD Dr. Jan Kottner, Scientific Director Clinical Research Center for Hair and Skin Science, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02557698    
Other Study ID Numbers: CRC-SP-ABC-13
First Posted: September 23, 2015    Key Record Dates
Results First Posted: March 7, 2017
Last Update Posted: April 5, 2017
Last Verified: March 2017