Effectiveness of Using an Oil Bath Additive

NCT02557698 | Completed Results

• 1 other identifier: CRC-SP-ABC-13
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerosis Cutis

Outcome Measures

Primary Outcomes (1)

• Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm

  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

  Day 28 +/- 3

Secondary Outcomes (29)

• Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm

  Day 14 +/- 2

• Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg

  Day 14 +/- 2

• Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg

  Day 28 +/- 3

• Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg

  Day 14 +/- 2

• Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg

  Day 28 +/- 3

Study Arms (2)

Balneum oil bath

EXPERIMENTAL

Balneum oil bath, bathing every other day for four weeks

Other: Balneum oil bath

standard skin cleanser

NO INTERVENTION

Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks

Interventions

Balneum oil bath OTHER

Balneum oil bath

Eligibility Criteria

• Age: 6 Months - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Systemic immunosuppressive or immunomodulatory therapy

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

• 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.

  PMID: 27815985 DERIVED

Results Point of Contact

• Title: Dr. Jan Kottner
• Organization: Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergology Charité - Universitätsmedizin Berlin

jan.kottner@charite.de

+49 30 450 518218

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director Clinical Research Center for Hair and Skin Science

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 23, 2015
• Study Start: November 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 5, 2017
• Results First Posted: March 7, 2017

Record last verified: 2017-03

Locations

DE (1)