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Effectiveness of Using an Oil Bath Additive

Charité University Medicine Berlin logo

Charité University Medicine Berlin

Status

Completed

Conditions

Xerosis Cutis

Treatments

Other: Balneum oil bath

Study type

Interventional

Funder types

Other

Identifiers

NCT02557698
CRC-SP-ABC-13

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

6 months to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Balneum oil bath
Experimental group
Description:
Balneum oil bath, bathing every other day for four weeks
Treatment:
Other: Balneum oil bath
standard skin cleanser
No Intervention group
Description:
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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