Xerosis CutisNCT02557698

Effectiveness of Using an Oil Bath Additive

A study testing Balneum oil bath in people with Xerosis Cutis, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 6 months to 85 yearsHealthy volunteers can take part
Conditions the study is for: Xerosis Cutis
What is being tested?: Balneum oil bath
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteGermany
Study dates: Nov 2014to Sep 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 85 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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 locations and contacts

1 site in 1 country.

Germany1 site

Charité - Universitätsmedizin Berlin
Berlin, 10117

Other trials in Germany

About this study

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

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
Being tested: Balneum oil bath

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Balneum oil bathOther

Study groups in NCT02557698
Study group	Role	What they receive
Balneum oil bath	Experimental	Balneum oil bath, bathing every other day for four weeks Receives: Other: Balneum oil bath
standard skin cleanser	No intervention	Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 28 +/- 3

Secondary outcomes (29)

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 2 (day14) - intermediate visit
Measured: Day 14 +/- 2
Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg
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 at the right lateral lower leg.
Visit 2 (day14)
Measured: Day 14 +/- 2
Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg
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 at the right lateral lower leg.
Visit 3 (day 28)
Measured: Day 28 +/- 3
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg
SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out.
Visit 2 (day 14)
Measured: Day 14 +/- 2
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg
SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher is SCH. Per investigational site three replicate measurements were carried out.
Visit 3 (day 28)
Measured: Day 28 +/- 3
Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness
Measured: Day 14 +/- 2
Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness
Measured: Day 28 +/- 3
Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.
Measured: Day 14 +/- 2
Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.
Measured: Day 28 +/- 3
Skin Surface pH at the Right Lateral Lower Leg
Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH of the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.
Measured: Day 14 +/- 2
Skin Surface pH at the Right Lateral Lower Leg
Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH of the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.
Measured: Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Left Arm
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day14) - intermediate visit
Measured: Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Left Arm
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness by the investigator using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks)
Measured: Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Right Arm
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day14)
Measured: Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Right Arm
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28)
Measured: Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Left Lower Leg
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14) - intermediate visit
Measured: Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Left Lower Leg
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28) - end of study visit
Measured: Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Right Lower Leg
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14) - intermediate visit
Measured: Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Right Lower Leg
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28)
Measured: Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Trunk
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14)
Measured: Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Trunk
The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28) - end of study visit
Measured: Day 28 +/- 3
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm
SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out.
Visit 2 (day 14)
Measured: Day 14 +/- 2
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm
SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out.
Visit 3 (day 28)
Measured: Day 28 +/- 3
Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness
Measured: Day 14 +/- 2
Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness
Measured: Day 28 +/- 3
Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.
Measured: Day 14 +/- 2
Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.
Measured: Day 28 +/- 3
Skin Surface pH at the Left Midvolar Forearm
Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH on the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.
Measured: Day 14 +/- 2
Skin Surface pH at the Left Midvolar Forearm
Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH on the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.
Measured: Day 28 +/- 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Sep 2015

First posted23 Sep 2015 (estimated)
Study startNov 2014
Primary completionApr 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Xerosis CutisStudies of the same condition, open and under way.
More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02557698
Sponsor's protocol ID: CRC-SP-ABC-13
Status last verified: Mar 2017
First submitted: 21 Sep 2015
Last updated: 5 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27815985

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Xerosis Cutis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02557698
Acronym / sponsor ID: CRC-SP-ABC-13
Conditions: Xerosis Cutis
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Charite University, Berlin, GermanyUniversity, hospital or other
Study start: Nov 2014
Primary completion: Apr 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 23 Sep 2015 (estimated)
Results: Posted 7 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Balneum oil bath	Experimental	Other: Balneum oil bathBalneum oil bath, bathing every other day for four weeks
standard skin cleanser	No intervention	–Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks

Who may qualify

Ages: 6 months to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Balneum oil bath	Other	Balneum oil bath

Primary outcome

Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm
Time frame: Day 28 +/- 3
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

29 secondary outcomes

Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm
Time frame: Day 14 +/- 2
Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg
Time frame: Day 14 +/- 2
Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg
Time frame: Day 28 +/- 3
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg
Time frame: Day 14 +/- 2
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg
Time frame: Day 28 +/- 3
Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg
Time frame: Day 14 +/- 2
Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg
Time frame: Day 28 +/- 3
Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg
Time frame: Day 14 +/- 2
Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg
Time frame: Day 28 +/- 3
Skin Surface pH at the Right Lateral Lower Leg
Time frame: Day 14 +/- 2
Skin Surface pH at the Right Lateral Lower Leg
Time frame: Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Left Arm
Time frame: Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Left Arm
Time frame: Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Right Arm
Time frame: Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Right Arm
Time frame: Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Left Lower Leg
Time frame: Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Left Lower Leg
Time frame: Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Right Lower Leg
Time frame: Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Right Lower Leg
Time frame: Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Trunk
Time frame: Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Trunk
Time frame: Day 28 +/- 3
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm
Time frame: Day 14 +/- 2
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm
Time frame: Day 28 +/- 3
Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm
Time frame: Day 14 +/- 2
Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm
Time frame: Day 28 +/- 3
Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm
Time frame: Day 14 +/- 2
Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm
Time frame: Day 28 +/- 3
Skin Surface pH at the Left Midvolar Forearm
Time frame: Day 14 +/- 2
Skin Surface pH at the Left Midvolar Forearm
Time frame: Day 28 +/- 3

Results and safety

Results posted to the registry on 7 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Balneum Oil Bath	30	30
Standard Skin Cleanser	30	30

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

Time frame: Day 28 +/- 3. Mean (Standard Deviation). Unit: g/m2/h

Measure	Balneum Oil Bath n = 30	Standard Skin Cleanser n = 30
Value	10.0 (2.0)	11.9 (2.5)

Balneum Oil Bath vs Standard Skin Cleanser: Mean Difference (Final Values): -1.9 (95% CI -3.1 to -0.8), p = 0.002, t-test, 2 sided

Population analysed: Male or female gender, aged between 6 months and 85 years

29 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Balneum Oil Bath	0 of 30 (0%)	0 of 30 (0%)	Not reported
Standard Skin Cleanser	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27815985Kottner 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Balneum oil bath in people with Xerosis Cutis, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm (time frame: Day 28 +/- 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02557698, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.