EczemaBEEPNCT01142999
Feasibility Study of Barrier Enhancement for Eczema Prevention
A study testing Sunflower oil, Aquaphor ointment and Cetaphil cream in people with Eczema, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this protocol is to determine the feasibility of doing larger follow-up studies examining whether emollients used from birth can prevent eczema in high-risk babies and to help investigators find out if emollients (moisturizing skin creams) used from birth can prevent eczema in high-risk babies. Read more about this study
- Who is it for?
- Ages 1 minute to 6 months
- Conditions the study is for
- Eczema
- What is being tested?
- Sunflower oil, Aquaphor ointment and Cetaphil cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Sep 2012
- 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 1 minute to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant must have a parent or sibling with a history of at least one of the following: eczema, allergic rhinitis or asthma
- Infant in overall good health
- Mother between the ages of 16 and 45 years of age at delivery; infant from birth thru 6 months of age
- Capable of giving informed consent
Who cannot join
- Preterm birth defined as birth prior to 37 weeks gestation
- Major congenital anomaly
- Hydrops fetalis
- Significant dermatitis at birth not including seborrheic dermatitis ("cradle cap")
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)
The purpose of this protocol is to determine the feasibility of doing larger follow-up studies examining whether emollients used from birth can prevent eczema in high-risk babies and to help investigators find out if emollients (moisturizing skin creams) used from birth can prevent eczema in high-risk babies. Hypothesis: Enhancing the skin barrier from birth using emollients will prevent or delay the onset of eczema, especially in predisposed infants.
- Conditions
- Eczema
- Being tested
- Sunflower oil, Control group, Aquaphor ointment, Cetaphil cream
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunflower oilDrug
Also called Moisturizers
One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
Control groupDrug
This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.
Aquaphor ointmentDrug
One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
Cetaphil creamDrug
One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (moisturizer group) | Active comparator | One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants. Receives: Drug: Sunflower oil; Drug: Aquaphor ointment; Drug: Cetaphil cream |
| Control group (no moisturizers) | Active comparator | This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants. Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of families willing to be randomized.
Determine proportion of families willing to be randomized in order to design larger study in the future.
Measured: 6 months
Secondary outcomes (10)
Proportion of families eligible for the trial, willing to participate
Measured: 6 months
Proportion of families who found the interventions acceptable
Measured: 6 months
Reported adherence with intervention
Measured: 6 months
Proportion of families for whom the blinding of the assessor to the allocation ostatus was not compromised
Measured: 6 months
Amount of contamination as a result of increased awareness in the control group
Measured: 6 months
Percentage of missing data and early withdrawal rates
Measured: 6 months
Incidence of emollient-related adverse events
Measured: 6 months
Incidence of eczema at 6 and 12 months
Measured: 12 months
Age at onset of eczema
Measured: 6 months
Filaggrin mutation status
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2011 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Investigators
- Eric L. Simpson, M.D., M.C.R., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142999
- Sponsor's protocol ID
- BEEP
- Acronym
- BEEP
- Status last verified
- Jun 2010
- First submitted
- 10 Jun 2010
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)
- ClinicalTrials.gov ID
- NCT01142999
- Acronym / sponsor ID
- BEEP / BEEP
- Conditions
- Eczema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 14 Jun 2010 (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 purpose of this protocol is to determine the feasibility of doing larger follow-up studies examining whether emollients used from birth can prevent eczema in high-risk babies and to help investigators find out if emollients (moisturizing skin creams) used from birth can prevent eczema in high-risk babies. Hypothesis: Enhancing the skin barrier from birth using emollients will prevent or delay the onset of eczema, especially in predisposed infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (moisturizer group) | Active comparator | Drug: Sunflower oil, Drug: Aquaphor ointment, Drug: Cetaphil creamOne group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants. |
| Control group (no moisturizers) | Active comparator | Drug: Control groupThis group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants. |
Who may qualify
- Ages
- 1 minute to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participant must have a parent or sibling with a history of at least one of the following: eczema, allergic rhinitis or asthma
- Infant in overall good health
- Mother between the ages of 16 and 45 years of age at delivery; infant from birth thru 6 months of age
- Capable of giving informed consent
Key exclusion criteria (7 listed)
- Preterm birth defined as birth prior to 37 weeks gestation
- Major congenital anomaly
- Hydrops fetalis
- Significant dermatitis at birth not including seborrheic dermatitis ("cradle cap")
- Any immunodeficiency disorder or severe genetic skin disorder
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 |
|---|---|---|
| Sunflower oilAlso: MoisturizersOne group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants. | Drug | Intervention (moisturizer group) |
| Control groupThis group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants. | Drug | Control group (no moisturizers) |
| Aquaphor ointmentOne group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants. | Drug | Intervention (moisturizer group) |
| Cetaphil creamOne group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants. | Drug | Intervention (moisturizer group) |
Primary outcome
Proportion of families willing to be randomized.
Time frame: 6 months
Determine proportion of families willing to be randomized in order to design larger study in the future.
10 secondary outcomes
Proportion of families eligible for the trial, willing to participate
Time frame: 6 months
Proportion of families who found the interventions acceptable
Time frame: 6 months
Reported adherence with intervention
Time frame: 6 months
Proportion of families for whom the blinding of the assessor to the allocation ostatus was not compromised
Time frame: 6 months
Amount of contamination as a result of increased awareness in the control group
Time frame: 6 months
Percentage of missing data and early withdrawal rates
Time frame: 6 months
Incidence of emollient-related adverse events
Time frame: 6 months
Incidence of eczema at 6 and 12 months
Time frame: 12 months
Age at onset of eczema
Time frame: 6 months
Filaggrin mutation status
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
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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 L. Simpson, M.D., M.C.R. principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunflower oil, Aquaphor ointment and Cetaphil cream in people with 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Aug 2011. 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?
Results are not available in the source record.
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?
Proportion of families willing to be randomized. (time frame: 6 months). 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 5 Aug 2011.