Clinical trial NCT02557698: Effectiveness of Using an Oil Bath Additive
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerosis Cutis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm
timeFrame: Day 28 +/- 3
Secondary outcomes:
measure: Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm
timeFrame: Day 14 +/- 2
measure: Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg
timeFrame: Day 14 +/- 2
measure: Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg
timeFrame: Day 28 +/- 3
measure: Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg
timeFrame: Day 14 +/- 2
measure: Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg
timeFrame: Day 28 +/- 3
measure: Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg
timeFrame: Day 14 +/- 2
measure: Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg
timeFrame: Day 28 +/- 3
measure: Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg
timeFrame: Day 14 +/- 2
measure: Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg
timeFrame: Day 28 +/- 3
measure: Skin Surface pH at the Right Lateral Lower Leg
timeFrame: Day 14 +/- 2
measure: Skin Surface pH at the Right Lateral Lower Leg
timeFrame: Day 28 +/- 3
measure: Overall Dry Skin (ODS) Score at the Left Arm
timeFrame: Day 14 +/- 2
measure: Overall Dry Skin (ODS) Score at the Left Arm
timeFrame: Day 28 +/- 3
measure: Overall Dry Skin (ODS) Score at the Right Arm
timeFrame: Day 14 +/- 2
measure: Overall Dry Skin (ODS) Score at the Right Arm
timeFrame: Day 28 +/- 3
measure: Overall Dry Skin (ODS) Score at the Left Lower Leg
timeFrame: Day 14 +/- 2
measure: Overall Dry Skin (ODS) Score at the Left Lower Leg
timeFrame: Day 28 +/- 3
measure: Overall Dry Skin (ODS) Score at the Right Lower Leg
timeFrame: Day 14 +/- 2
measure: Overall Dry Skin (ODS) Score at the Right Lower Leg
timeFrame: Day 28 +/- 3
measure: Overall Dry Skin (ODS) Score at the Trunk
timeFrame: Day 14 +/- 2
measure: Overall Dry Skin (ODS) Score at the Trunk
timeFrame: Day 28 +/- 3
measure: Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm
timeFrame: Day 14 +/- 2
measure: Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm
timeFrame: Day 28 +/- 3
measure: Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm
timeFrame: Day 14 +/- 2
measure: Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm
timeFrame: Day 28 +/- 3
measure: Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm
timeFrame: Day 14 +/- 2
measure: Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm
timeFrame: Day 28 +/- 3
measure: Skin Surface pH at the Left Midvolar Forearm
timeFrame: Day 14 +/- 2
measure: Skin Surface pH at the Left Midvolar Forearm
timeFrame: Day 28 +/- 3
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
References:
citation: 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.