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

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

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.

Study Overview

• Status: Completed
• Conditions: Xerosis Cutis; Xerosis; Dry Skin; Eczema
• Intervention / Treatment: Other: virgin coconut oil; Other: virgin jojoba oil; Other: virgin almond oil; Other: white petrolatum ointment

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • University of Arizona, Banner-University Medical Center
  • California
    • Sacramento, California, United States, 95816
      • University of California, Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 days

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: University of California, Davis
• Investigators: Principal Investigator: Vivian Y Shi, MD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): December 12, 2017

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema; Dermatologic Agents; Emollients; Petrolatum
• Other Study ID Numbers: 1701110479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No