Effectiveness of Using an Oil Bath Additive

March 7, 2017 updated by: PD Dr. Jan Kottner, Charite University, Berlin, Germany

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charite - Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 85 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Balneum oil bath
Balneum oil bath, bathing every other day for four weeks
Other: Balneum oil bath
No Intervention: standard skin cleanser
Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 28 +/- 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm
Time Frame: Day 14 +/- 2

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
Day 14 +/- 2
Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg
Time Frame: Day 14 +/- 2

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)
Day 14 +/- 2
Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg
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 at the right lateral lower leg.

Visit 3 (day 28)
Day 28 +/- 3
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg
Time Frame: Day 14 +/- 2

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)
Day 14 +/- 2
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg
Time Frame: Day 28 +/- 3

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)
Day 28 +/- 3
Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg
Time Frame: Day 14 +/- 2
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
Day 14 +/- 2
Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg
Time Frame: Day 28 +/- 3
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
Day 28 +/- 3
Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg
Time Frame: Day 14 +/- 2
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.
Day 14 +/- 2
Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg
Time Frame: Day 28 +/- 3
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.
Day 28 +/- 3
Skin Surface pH at the Right Lateral Lower Leg
Time Frame: Day 14 +/- 2
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.
Day 14 +/- 2
Skin Surface pH at the Right Lateral Lower Leg
Time Frame: Day 28 +/- 3
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.
Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Left Arm
Time Frame: Day 14 +/- 2

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
Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Left Arm
Time Frame: Day 28 +/- 3

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)
Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Right Arm
Time Frame: Day 14 +/- 2

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)
Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Right Arm
Time Frame: Day 28 +/- 3

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)
Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Left Lower Leg
Time Frame: Day 14 +/- 2

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
Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Left Lower Leg
Time Frame: Day 28 +/- 3

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
Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Right Lower Leg
Time Frame: Day 14 +/- 2

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
Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Right Lower Leg
Time Frame: Day 28 +/- 3

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)
Day 28 +/- 3
Overall Dry Skin (ODS) Score at the Trunk
Time Frame: Day 14 +/- 2

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)
Day 14 +/- 2
Overall Dry Skin (ODS) Score at the Trunk
Time Frame: Day 28 +/- 3

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
Day 28 +/- 3
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm
Time Frame: Day 14 +/- 2

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)
Day 14 +/- 2
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm
Time Frame: Day 28 +/- 3

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)
Day 28 +/- 3
Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm
Time Frame: Day 14 +/- 2
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
Day 14 +/- 2
Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm
Time Frame: Day 28 +/- 3
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
Day 28 +/- 3
Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm
Time Frame: Day 14 +/- 2
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.
Day 14 +/- 2
Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm
Time Frame: Day 28 +/- 3
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.
Day 28 +/- 3
Skin Surface pH at the Left Midvolar Forearm
Time Frame: Day 14 +/- 2
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.
Day 14 +/- 2
Skin Surface pH at the Left Midvolar Forearm
Time Frame: Day 28 +/- 3
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.
Day 28 +/- 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRC-SP-ABC-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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