Effectiveness of Using an Oil Bath Additive

Xerosis Cutis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557698
• Other study ID #: CRC-SP-ABC-13
• Status: Completed
• Phase: N/A
• First received: September 21, 2015
• Last updated: September 22, 2015
• Start date: November 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Xerosis Cutis

Intervention

Other:
• Balneum oil bath

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transepidermal water loss (TEWL) in g/m2/h at the left mid volar forearm		Day 28 +/- 3	No
Secondary	Transepidermal water loss (TEWL) in g/m2/h at the left mid volar forearm		Day 14 +/- 2	No
Secondary	Transepidermal water loss (TEWL) in g/m2/h at the right lateral lower leg		Day 14 +/- 2	No
Secondary	Transepidermal water loss (TEWL) in g/m2/h at the right lateral lower leg		Day 28 +/- 3	No
Secondary	Stratum corneum hydration (SCH) in arbitrary units at the right lateral lower leg and left volar forearm		Day 14 +/- 2	No
Secondary	Stratum corneum hydration (SCH) in arbitrary units at the right lateral lower leg and left volar forearm		Day 28 +/- 3	No
Secondary	Skin surface mean roughness (Ra) in µm at the right lateral lower leg and left volar forearm		Day 14 +/- 2	No
Secondary	Skin surface mean roughness (Ra) in µm at the right lateral lower leg and left volar forearm		Day 28 +/- 3	No
Secondary	Skin surface mean roughness (Rz) in µm at the right lateral lower leg and left volar forearm		Day 14 +/- 2	No
Secondary	Skin surface mean roughness (Rz) in µm at the right lateral lower leg and left volar forearm		Day 28 +/- 3	No
Secondary	Skin surface pH at the right lateral lower leg and left volar forearm		Day 14 +/- 2	No
Secondary	Skin surface pH at the right lateral lower leg and left volar forearm		Day 28 +/- 3	No
Secondary	Overall Dry Skin (ODS) score at the right and left lateral lower legs, at the left and right arms, at the trunk		Day 14 +/- 2	No
Secondary	Overall Dry Skin (ODS) score at the right and left lateral lower legs, at the left and right arms, at the trunk		Day 28 +/- 3	No