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

Not Applicable

Completed

• Conditions: Xerosis; Dry Skin; Eczema; Xerosis Cutis
• Interventions: Other: virgin jojoba oil; Other: virgin coconut oil; Other: white petrolatum ointment; Other: virgin almond oil

• Registration Number: NCT03093597
• Lead Sponsor: University of Arizona

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 Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study Start: 2017-03-27
• Study First Posted: 2017-03-28
• Primary Completion: 2017-06-01
• Study Completion: 2017-12-12
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
virgin jojoba oil	virgin jojoba oil	All subjects will apply virgin jojoba oil to a previously randomize section of the skin on the left or right forearm
virgin coconut oil	virgin coconut oil	All subjects will apply virgin coconut oil to a previously randomize section of the skin on the left or right forearm.
white petrolatum ointment	white petrolatum ointment	All subjects will apply white petrolatum ointment to a previously randomize section of the skin on the left or right forearm.
virgin almond oil	virgin almond oil	All subjects will apply virgin almond oil to a previously randomize section of the skin on the left or right forearm

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

University of Arizona, Banner-University Medical Center; 🇺🇸 Tucson, Arizona, United States

University of California, Davis; 🇺🇸 Sacramento, California, United States