XerosisNCT03093597
Skin Barrier Biophysical Properties and Clinical Appearance After Moisturizer in Dry Skin
A study testing virgin coconut oil, virgin jojoba oil and virgin almond oil in people with Xerosis and Xerosis Cutis, run by University of Arizona at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Xerosis, Xerosis Cutis, Dry Skin; Eczema
- What is being tested?
- virgin coconut oil, virgin jojoba oil and virgin almond oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Mar 2017to 12 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects who do not fit the inclusion criteria.
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Davis
Sacramento, California, 95816
University of Arizona, Banner-University Medical Center
Tucson, Arizona, 85704
About this study
Official title: 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.
Read the 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.
- Conditions
- Xerosis, Xerosis Cutis, Dry Skin; Eczema
- Being tested
- virgin coconut oil, virgin jojoba oil, virgin almond oil, white petrolatum ointment
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: 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. Receives: Other: white petrolatum ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start27 Mar 2017
- Primary completion1 Jun 2017
- Study completion12 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerosisStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Vivian Y Shi, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093597
- Sponsor's protocol ID
- 1701110479
- Status last verified
- Jan 2017
- First submitted
- 23 Mar 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Skin Barrier Biophysical Properties and Clinical Appearance After Moisturizer Use in Patients With Dry Skin
- ClinicalTrials.gov ID
- NCT03093597
- Acronym / sponsor ID
- 1701110479
- Conditions
- Xerosis, Xerosis Cutis, Dry Skin; Eczema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| virgin coconut oil | Active comparator | Other: virgin coconut oilAll subjects will apply virgin coconut oil to a previously randomize section of the skin on the left or right forearm. |
| virgin jojoba oil | Active comparator | Other: virgin jojoba oilAll subjects will apply virgin jojoba oil to a previously randomize section of the skin on the left or right forearm |
| virgin almond oil | Active comparator | Other: virgin almond oilAll subjects will apply virgin almond oil to a previously randomize section of the skin on the left or right forearm |
| white petrolatum ointment | Active comparator | Other: white petrolatum ointmentAll subjects will apply white petrolatum ointment to a previously randomize section of the skin on the left or right forearm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Subjects who do not fit the inclusion criteria.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virgin coconut oilOne 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. | Other | virgin coconut oil |
| virgin jojoba oilOne 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. | Other | virgin jojoba oil |
| virgin almond oilOne 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. | Other | virgin almond oil |
| white petrolatum ointmentOne 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. | Other | white petrolatum ointment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Xerosis
Active, not recruiting
Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
Recruiting
Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
Xerosis, Dry Skin
RecruitingPhase 2
Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors
Acneiform Eruption Due to Chemical, Xerosis Cutis
Recruiting
Novel Skin Barrier Product Versus Petrolatum for Skin Barrier Dysfunction
Psoriasis, Atopic Dermatitis
Recruiting
Study on the Effectiveness of an Emollient Cream Containing Pre and Postbiotic and Niacinamide 4% in the Treatment of Skin Xerosis and Itching in Oncological Patients Treated with Anti-EGFR
Xerosis Cutis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivian Y Shi, MD principal investigator
University of Arizona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virgin coconut oil, virgin jojoba oil and virgin almond oil in people with Xerosis and Xerosis Cutis, run by University of Arizona at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The appearance of xerosis (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.