NCT03093597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

March 27, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2017

Completed
Last Updated

October 11, 2018

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

March 23, 2017

Last Update Submit

October 9, 2018

Conditions

XerosisXerosis CutisDry Skin; Eczema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Skin barrier biophysical properties of xerosis

    14 days

Study Arms (4)

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.

Other: virgin coconut oil

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

Other: virgin jojoba oil

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

Other: virgin almond oil

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.

Other: white petrolatum ointment

Interventions

virgin coconut oilOTHER

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 coconut oil
virgin jojoba oilOTHER

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 jojoba oil
virgin almond oilOTHER

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.

virgin almond oil
white petrolatum ointmentOTHER

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.

white petrolatum ointment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arizona, Banner-University Medical Center

Tucson, Arizona, 85704, United States

Location

University of California, Davis

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Vivian Y Shi, MD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2017

First Posted

March 28, 2017

Study Start

March 27, 2017

Primary Completion

June 1, 2017

Study Completion

December 12, 2017

Last Updated

October 11, 2018

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)