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Skin Barrier Biophysical Properties and Clinical Appearance After Moisturizer in Dry Skin

Primary Purpose

Xerosis, Xerosis Cutis, Dry Skin; Eczema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
virgin coconut oil
virgin jojoba oil
virgin almond oil
white petrolatum ointment
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male and female, at least 18 years of age
  2. Subject must receive a diagnosis of dry skin by a dermatologist.
  3. Subject must be able to comprehend and read the English language.

Exclusion Criteria:

  1. Subjects who do not fit the inclusion criteria.
  2. Subjects unable to or unwilling to comply with the study procedures
  3. Prior known allergy to white petrolatum, coconut oil, almond oil, or jojoba oil.
  4. People who have used products containing white petrolatum, jojoba oil, coconut oil, or almond oil within the past week.
  5. People with a known diagnosis of ichthyosis.
  6. A subject who, in the opinion of the investigator, will be un-cooperative or unable to comply with study procedures.
  7. Subject unable to speak or read the English language, since all consents and instructions will be provided in English.
  8. Those that are prisoners or cognitively impaired

Sites / Locations

  • University of Arizona, Banner-University Medical Center
  • University of California, Davis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

virgin coconut oil

virgin jojoba oil

virgin almond oil

white petrolatum ointment

Arm Description

All subjects will apply virgin coconut oil to a previously randomize section of the skin on the left or right forearm.

All subjects will apply virgin jojoba oil to a previously randomize section of the skin on the left or right forearm

All subjects will apply virgin almond oil to a previously randomize section of the skin on the left or right forearm

All subjects will apply white petrolatum ointment to a previously randomize section of the skin on the left or right forearm.

Outcomes

Primary Outcome Measures

The appearance of xerosis
The clinical severity of xerosis of the 4 location will be graded by a trained observed using a previously validated Dry Skin Scale and by analysis of the digital photos.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2017
Last Updated
October 9, 2018
Sponsor
University of Arizona
Collaborators
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03093597
Brief Title
Skin Barrier Biophysical Properties and Clinical Appearance After Moisturizer in Dry Skin
Official Title
Evaluating Skin Barrier Biophysical Properties and Clinical Appearance After Moisturizer Use in Patients With Dry Skin
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
December 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to compare the changes in the appearance of dry skin after the use various moisturizers: white petrolatum ointment, coconut oil, jojoba oil, and almond oil in patients with dry skin.
Detailed Description
The goal of this study is to compare how the appearance of dry skin changes before and after the use of following moisturizers: white petrolatum, coconut oil, jojoba oil and almond oil). Up to 40 subjects from Banner-University Medical Center/University of Arizona dermatology clinics and University of California, Davis dermatology clinics (up to 20 subjects per site) who have dry skin will be enrolled in this study and randomized to receive the four moisturizers on four locations on their forearms.There will be a total of 3 study sessions: baseline, and approximately 1 and 2 weeks for follow up assessment. At each visit, dry skin severity will be evaluated by a trained observer using a validated Dry Skin Score, skin barrier biophysical properties (transepidermal water loss and hydration) will be measured, and digital photos of the test sites will be taken for image analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerosis, Xerosis Cutis, Dry Skin; Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
virgin coconut oil
Arm Type
Active Comparator
Arm Description
All subjects will apply virgin coconut oil to a previously randomize section of the skin on the left or right forearm.
Arm Title
virgin jojoba oil
Arm Type
Active Comparator
Arm Description
All subjects will apply virgin jojoba oil to a previously randomize section of the skin on the left or right forearm
Arm Title
virgin almond oil
Arm Type
Active Comparator
Arm Description
All subjects will apply virgin almond oil to a previously randomize section of the skin on the left or right forearm
Arm Title
white petrolatum ointment
Arm Type
Active Comparator
Arm Description
All subjects will apply white petrolatum ointment to a previously randomize section of the skin on the left or right forearm.
Intervention Type
Other
Intervention Name(s)
virgin coconut oil
Intervention Description
One of the four locations (right proximal forearm, right distal forearm, left proximal forearm, left distal forearm) on the forearm will be selected to receive virgin coconut oil application twice daily for 2 weeks.
Intervention Type
Other
Intervention Name(s)
virgin jojoba oil
Intervention Description
One of the four locations (right proximal forearm, right distal forearm, left proximal forearm, left distal forearm) on the forearm will be selected to receive virgin jojoba oil application twice daily for 2 weeks.
Intervention Type
Other
Intervention Name(s)
virgin almond oil
Intervention Description
One of the four locations (right proximal forearm, right distal forearm, left proximal forearm, left distal forearm) on the forearm will be selected to receive virgin almond oil application twice daily for 2 weeks.
Intervention Type
Other
Intervention Name(s)
white petrolatum ointment
Intervention Description
One of the four locations (right proximal forearm, right distal forearm, left proximal forearm, left distal forearm) on the forearm will be selected to receive white petrolatum ointment application twice daily for 2 weeks.
Primary Outcome Measure Information:
Title
The appearance of xerosis
Description
The clinical severity of xerosis of the 4 location will be graded by a trained observed using a previously validated Dry Skin Scale and by analysis of the digital photos.
Time Frame
14 days
Other Pre-specified Outcome Measures:
Title
Skin barrier biophysical properties of xerosis
Description
Transepidermal water loss (TEWL) and stratum corneum hydration status will be measured using hand-held, noninvasive, skin barrier measuring devices (Tewameter and moistureMeter)
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female, at least 18 years of age Subject must receive a diagnosis of dry skin by a dermatologist. Subject must be able to comprehend and read the English language. Exclusion Criteria: Subjects who do not fit the inclusion criteria. Subjects unable to or unwilling to comply with the study procedures Prior known allergy to white petrolatum, coconut oil, almond oil, or jojoba oil. People who have used products containing white petrolatum, jojoba oil, coconut oil, or almond oil within the past week. People with a known diagnosis of ichthyosis. A subject who, in the opinion of the investigator, will be un-cooperative or unable to comply with study procedures. Subject unable to speak or read the English language, since all consents and instructions will be provided in English. Those that are prisoners or cognitively impaired
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian Y Shi, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona, Banner-University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Skin Barrier Biophysical Properties and Clinical Appearance After Moisturizer in Dry Skin

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