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

Xerosis Cutis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093597
• Other study ID #: 1701110479
• Status: Completed
• Phase: N/A
• Start date: March 27, 2017
• Est. completion date: December 12, 2017

Study information

• Verified date: January 2017
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 12, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Skin; Eczema
• Xerosis
• Xerosis Cutis

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Davis	Sacramento	California
United States	University of Arizona, Banner-University Medical Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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