Atopic DermatitisEESNCT01291940
The Effects of Emollient Therapy on the Skin Barrier
A study testing Pediatric Moisturizer and Adult Moisturizer in people with Atopic Dermatitis and Eczema, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The goal of this study is to better understand what effect emollients (moisturizers) have on the skin in young children and adults. Subjects will be recruited from PI and Sub-I clinics and Oregon Health \& Science University (OHSU) research opportunities website. 1. Read more about this study
- Who is it for?
- Ages 3 months to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- Pediatric Moisturizer and Adult Moisturizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2014
- 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 3 months to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Enrollment in the BEEP emollient intervention study (IRB #6083)
- Overall good health
- Have a history of atopic dermatitis
- 12 years or older
- 4 x 4 cm of non-lesional skin on both inner forearms
- No other conditions that would make the use of the four emollients harmful to the subject, such as known allergy to an emollient or a component o the emollient
Who cannot join
- Have a history of or are being evaluated for a skin barrier disease
- Have an active skin infection
- Are receiving phototherapy
- Any immunodeficiency disorder or severe genetic skin disorder
- Any other serious condition that would make the use of emollients inadvisable
- Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention
Show all 9Show fewer
- Adult Study
- Use of topical steroids on the inner forearms or oral immunosuppressive medications for 4 weeks prior to participation in the study.
- Receiving phototherapy or systemic immunosuppressive therapy three months prior to participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University Center for Health & Healing
Portland, Oregon, 97239
About this study
Official title: The Effects of Emollient Therapy on the Skin Barrier Function
The goal of this study is to better understand what effect emollients (moisturizers) have on the skin in young children and adults.
Subjects will be recruited from PI and Sub-I clinics and Oregon Health \& Science University (OHSU) research opportunities website.
Read more
- Adult and Adolescent Study: Moisturizer Intervention - There will be 2-3 visits for this study: a screening visit, a baseline visit, and a final visit. Adults with a history of eczema will be asked to apply one of four possible moisturizers to one arm and nothing to the other arm for four weeks. The moisturizers, which will be assigned to the subjects, include either Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, or Vaseline 100% Petroleum Jelly. Subjects can use other skin treatments as needed for their skin condition, but may not treat the arms during the study. Non-invasive tests of the skin will be made at Visit 1 and after four weeks (Visit 2). The skin measurements that will be performed are:
- Transepidermal loss (TEWL)- measures how much water is lost across the skin barrier
- Skin Cohesion and TEWL - TEWL after 5, 10, 15, and 20 tape strips will measure skin barrier function after tape-stripping
- Skin electrical capacitance - measures the moisture in the top layer of skin
- Skin pH - measures the acidity of the skin
- Stratum corneum cohesion assay - tape-stripping to measure the protein removed from the top layer of skin
- Lipidomic analysis - measures the lipids, or oils, in the top layer of skin Control - There will be 1-2 visits for this group: a screening visit and baseline visit, which can be combined. Non-invasive tests of the skin will be taken and include the skin measurements that will be performed are the same as the Moisturizer Intervention group.
- Pediatric Study: There will be 2-3 visits for this study: a screening visit, a baseline visit, and a final visit. Infants and toddlers between 3 months and 3 years of age without a history of skin barrier diseases will be assigned to a moisturizer, which include either Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, or Aveeno Skin Relief Moisture Repair Cream. Non-invasive tests of the skin will be made at Visit 1 and after four weeks (Visit 2).
- TEWL- measures how much water is lost across the skin barrier
- Skin electrical capacitance - measures the moisture in the top layer of skin
- Skin pH - measures the acidity of the skin
- Conditions
- Atopic Dermatitis, Eczema
- Being tested
- Pediatric Moisturizer, Adult Moisturizer
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric MoisturizerOther
Also called Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, Aveeno Skin Relief Moisture Repair Cream
Apply moisturizer for four weeks daily to only one arm. Do not apply moisturizer to the other arm.
Adult MoisturizerOther
Also called Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, Vaseline 100% Petroleum Jelly
Apply moisturizer for four weeks daily to only one arm. Do not apply moisturizer to the other arm.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Moisturizer Intervention | Experimental | Apply one of four moisturizers to one arm daily for four weeks. Receives: Other: Pediatric Moisturizer |
| Adult Moisturizer Intervention | Experimental | Apply moisturizer to one arm once a day for four weeks. Receives: Other: Adult Moisturizer |
| Adult Control | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with improved skin barrier function as a result of emollient use
Change in TEWL measurements of intervention arms compared to controls.
Measured: 3-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Simpson, Oregon Health and Science University
- Investigators
- Eric Simpson, MD, MCR, Principal investigator, Oregon Health & Science University, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291940
- Sponsor's protocol ID
- Emollient Evaluation Study
- Acronym
- EES
- Status last verified
- Jul 2019
- First submitted
- 8 Feb 2011
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Emollient Therapy on the Skin Barrier Function
- ClinicalTrials.gov ID
- NCT01291940
- Acronym / sponsor ID
- EES / Emollient Evaluation Study
- Conditions
- Atopic Dermatitis, Eczema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Feb 2011 (estimated)
- 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 goal of this study is to better understand what effect emollients (moisturizers) have on the skin in young children and adults.
Subjects will be recruited from PI and Sub-I clinics and Oregon Health \& Science University (OHSU) research opportunities website.
- Adult and Adolescent Study: Moisturizer Intervention - There will be 2-3 visits for this study: a screening visit, a baseline visit, and a final visit. Adults with a history of eczema will be asked to apply one of four possible moisturizers to one arm and nothing to the other arm for four weeks. The moisturizers, which will be assigned to the subjects, include either Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, or Vaseline 100% Petroleum Jelly. Subjects can use other skin treatments as needed for their skin condition, but may not treat the arms during the study. Non-invasive tests of the skin will be made at Visit 1 and after four weeks (Visit 2). The skin measurements that will be performed are:
- Transepidermal loss (TEWL)- measures how much water is lost across the skin barrier
- Skin Cohesion and TEWL - TEWL after 5, 10, 15, and 20 tape strips will measure skin barrier function after tape-stripping
- Skin electrical capacitance - measures the moisture in the top layer of skin
- Skin pH - measures the acidity of the skin
- Stratum corneum cohesion assay - tape-stripping to measure the protein removed from the top layer of skin
- Lipidomic analysis - measures the lipids, or oils, in the top layer of skin Control - There will be 1-2 visits for this group: a screening visit and baseline visit, which can be combined. Non-invasive tests of the skin will be taken and include the skin measurements that will be performed are the same as the Moisturizer Intervention group.
- Pediatric Study: There will be 2-3 visits for this study: a screening visit, a baseline visit, and a final visit. Infants and toddlers between 3 months and 3 years of age without a history of skin barrier diseases will be assigned to a moisturizer, which include either Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, or Aveeno Skin Relief Moisture Repair Cream. Non-invasive tests of the skin will be made at Visit 1 and after four weeks (Visit 2).
- TEWL- measures how much water is lost across the skin barrier
- Skin electrical capacitance - measures the moisture in the top layer of skin
- Skin pH - measures the acidity of the skin
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pediatric Moisturizer Intervention | Experimental | Other: Pediatric MoisturizerApply one of four moisturizers to one arm daily for four weeks. |
| Adult Moisturizer Intervention | Experimental | Other: Adult MoisturizerApply moisturizer to one arm once a day for four weeks. |
| Adult Control | No intervention | –No intervention. |
Who may qualify
- Ages
- 3 months to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (9 listed)
- Adult Study
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 |
|---|---|---|
| Pediatric MoisturizerAlso: Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, Aveeno Skin Relief Moisture Repair CreamApply moisturizer for four weeks daily to only one arm. Do not apply moisturizer to the other arm. | Other | Pediatric Moisturizer Intervention |
| Adult MoisturizerAlso: Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, Vaseline 100% Petroleum JellyApply moisturizer for four weeks daily to only one arm. Do not apply moisturizer to the other arm. | Other | Adult Moisturizer Intervention |
Primary outcome
Number of participants with improved skin barrier function as a result of emollient use
Time frame: 3-4 weeks
Change in TEWL measurements of intervention arms compared to controls.
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 15 Jul 2019.
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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.
Eric Simpson, MD, MCR principal investigator
Oregon Health & Science University, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric Moisturizer and Adult Moisturizer in people with Atopic Dermatitis and Eczema, run by Oregon Health and Science University at 1 site 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 6 inclusion and 9 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 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of participants with improved skin barrier function as a result of emollient use (time frame: 3-4 weeks). 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 15 Jul 2019.