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

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ClinicalTrials.gov Identifier: NCT03093597
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
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.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 27, 2017
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : December 12, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Petrolatum

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.




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Skin barrier biophysical properties of xerosis [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093597


Locations
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United States, Arizona
University of Arizona, Banner-University Medical Center
Tucson, Arizona, United States, 85704
United States, California
University of California, Davis
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of Arizona
University of California, Davis
Investigators
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Principal Investigator: Vivian Y Shi, MD University of Arizona

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03093597     History of Changes
Other Study ID Numbers: 1701110479
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Petrolatum
Emollients
Dermatologic Agents