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

Sponsor

University of Arizona (Other)

Overall Status

Completed

CT.gov ID

NCT03093597

Collaborator

University of California, Davis (Other)

Enrollment

Locations

Arms

8.5

Actual Duration (Months)

18.5

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Xerosis Xerosis Cutis Dry Skin; Eczema	Other: virgin coconut oil Other: virgin jojoba oil Other: virgin almond oil Other: white petrolatum ointment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluating Skin Barrier Biophysical Properties and Clinical Appearance After Moisturizer Use in Patients With Dry Skin

Actual Study Start Date :

Mar 27, 2017

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Dec 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: virgin coconut oil All subjects will apply virgin coconut oil to a previously randomize section of the skin on the left or right forearm.	Other: virgin coconut oil 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.
Active Comparator: virgin jojoba oil All subjects will apply virgin jojoba oil to a previously randomize section of the skin on the left or right forearm	Other: virgin jojoba oil 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.
Active Comparator: virgin almond oil All subjects will apply virgin almond oil to a previously randomize section of the skin on the left or right forearm	Other: virgin almond oil 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.
Active Comparator: white petrolatum ointment All subjects will apply white petrolatum ointment to a previously randomize section of the skin on the left or right forearm.	Other: white petrolatum ointment 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.

Outcome Measures

Primary Outcome Measures

The appearance of xerosis [14 days]
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.

Other Outcome Measures

Skin barrier biophysical properties of xerosis [14 days]
Transepidermal water loss (TEWL) and stratum corneum hydration status will be measured using hand-held, noninvasive, skin barrier measuring devices (Tewameter and moistureMeter)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona, Banner-University Medical Center	Tucson	Arizona	United States	85704
2	University of California, Davis	Sacramento	California	United States	95816

Sponsors and Collaborators

University of Arizona
University of California, Davis

Investigators

Principal Investigator: Vivian Y Shi, MD, University of Arizona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Arizona

ClinicalTrials.gov Identifier:

NCT03093597

Other Study ID Numbers:

1701110479

First Posted:

Mar 28, 2017

Last Update Posted:

Oct 11, 2018

Last Verified:

Jan 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Eczema

Petrolatum

Study Results

No Results Posted as of Oct 11, 2018