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Clinical Trials/NCT03093597
NCT03093597CompletedNot Applicable

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

University of Arizona4 sites in 1 country37 target enrollmentStarted: March 27, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
37
Locations
4
Primary Endpoint
The appearance of xerosis

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

virgin jojoba oil

Active Comparator

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

Intervention: virgin jojoba oil (Other)

virgin almond oil

Active Comparator

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

Intervention: virgin almond oil (Other)

white petrolatum ointment

Active Comparator

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

Intervention: white petrolatum ointment (Other)

virgin coconut oil

Active Comparator

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

Intervention: virgin coconut oil (Other)

Outcomes

Primary Outcomes

The appearance of xerosis

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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