N/A N=60 Randomized Treatment

Effectiveness of Using an Oil Bath Additive

Xerosis Cutis

Bottom Line

View on ClinicalTrials.gov: NCT02557698 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm — 10.0; 11.9 g/m2/h — p=0.002

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Balneum oil bath (Other)
Age: Pediatric, Adult, Older Adult · 0+ yrs
Sex: All
Sponsor: Charite University, Berlin, Germany
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm	9.7; 12.0	<0.001 sig
SECONDARY Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm	9.7; 12.0	<0.001 sig
SECONDARY Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg	9.3; 11.0	0.017 sig
SECONDARY Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg	9.3; 11.0	0.017 sig
SECONDARY Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg	32.3; 28.0	0.025 sig
SECONDARY Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg	32.3; 28.0	0.025 sig
SECONDARY Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg	16.7; 18.4	0.066
SECONDARY Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg	16.7; 18.4	0.066
SECONDARY Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg	72.1; 79.6	0.059
SECONDARY Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg	72.1; 79.6	0.059
SECONDARY Skin Surface pH at the Right Lateral Lower Leg	5.2; 5.1	0.100
SECONDARY Skin Surface pH at the Right Lateral Lower Leg	5.2; 5.1	0.100
SECONDARY Overall Dry Skin (ODS) Score at the Left Arm	13; 13; 14; 13; 3; 4	0.914
SECONDARY Overall Dry Skin (ODS) Score at the Left Arm	13; 13; 14; 13; 3; 4	0.914
SECONDARY Overall Dry Skin (ODS) Score at the Right Arm	12; 9; 14; 18; 4; 3	0.585
SECONDARY Overall Dry Skin (ODS) Score at the Right Arm	12; 9; 14; 18; 4; 3	0.585
SECONDARY Overall Dry Skin (ODS) Score at the Left Lower Leg	2; 4; 17; 14; 11; 11	0.581
SECONDARY Overall Dry Skin (ODS) Score at the Left Lower Leg	2; 4; 17; 14; 11; 11	0.581
SECONDARY Overall Dry Skin (ODS) Score at the Right Lower Leg	3; 3; 16; 14; 11; 12	0.759
SECONDARY Overall Dry Skin (ODS) Score at the Right Lower Leg	3; 3; 16; 14; 11; 12	0.759
SECONDARY Overall Dry Skin (ODS) Score at the Trunk	19; 12; 10; 16; 0; 2	0.084
SECONDARY Overall Dry Skin (ODS) Score at the Trunk	19; 12; 10; 16; 0; 2	0.084
SECONDARY Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm	38.2; 34.1	0.029 sig
SECONDARY Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm	38.2; 34.1	0.029 sig
SECONDARY Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm	17.4; 18.2	0.365
SECONDARY Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm	17.4; 18.2	0.365
SECONDARY Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm	69.7; 70.9	0.662
SECONDARY Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm	69.7; 70.9	0.662
SECONDARY Skin Surface pH at the Left Midvolar Forearm	5.2; 5.1	0.687
SECONDARY Skin Surface pH at the Left Midvolar Forearm	5.2; 5.1	0.687

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02557698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.