Atopic DermatitisPhase 2NCT00806221
An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
A Phase 2 study testing emollient (Cetaphil cream) in people with Atopic Dermatitis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether early use of a bland emollient in newborns, prior to the clinical signs of skin disease, will delay the onset or prevent the development of atopic dermatitis. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- emollient (Cetaphil cream)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Nov 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- at least one parent diagnosed with Atopic Dermatitis
- one parent or sibling with hayfever or asthma
Who cannot join
- newborns with dermatitis at birth
- newborns born greater than four weeks prematurely
- newborns with medical problems necessitating prolonged hospitalization
- newborns diagnosed with any immune deficiency syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University, Department of Dermatology
Portland, Oregon, 97239
About this study
The purpose of this study is to determine whether early use of a bland emollient in newborns, prior to the clinical signs of skin disease, will delay the onset or prevent the development of atopic dermatitis.
Read the detailed description
All neonates will be treated with Cetaphil cream starting within 1 week of birth. All neonates enrolled will have an increased risk of developing atopic dermatitis because they have a family history of either asthma, hay fever, or atopic dermatitis. These neonates will then be followed for 2 years for the signs and symptoms of atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- emollient (Cetaphil cream)
- Keywords
- Atopic Dermatitis, Prevention, Skin Barrier
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emollient (Cetaphil cream)Drug
Cetaphil cream applied daily from birth
| Study group | Role | What they receive |
|---|---|---|
| Emollient | Experimental | Skin barrier protection from birth Receives: Drug: emollient (Cetaphil cream) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Skin Irritation
Measured: 1 and 2 year time points
Incidence of Skin Infection
Measured: 1 and 2 year timepoints
Compliance With Protocol
Measured: over two years
Secondary outcomes (1)
Development of Eczema
Measured: 1 and 2 year time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startNov 2006
- Primary completionNov 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Principal investigator, Eric Simpson, Oregon Health and Science University
- Investigators
- Eric Simpson, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806221
- Sponsor's protocol ID
- IRB00002726
- Status last verified
- Jun 2017
- First submitted
- 8 Dec 2008
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00806221
- Acronym / sponsor ID
- IRB00002726
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Prevention, Skin Barrier
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- Nov 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 10 Dec 2008 (estimated)
- Results
- Posted 11 Jul 2017
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 study is to determine whether early use of a bland emollient in newborns, prior to the clinical signs of skin disease, will delay the onset or prevent the development of atopic dermatitis.
Detailed description
All neonates will be treated with Cetaphil cream starting within 1 week of birth. All neonates enrolled will have an increased risk of developing atopic dermatitis because they have a family history of either asthma, hay fever, or atopic dermatitis. These neonates will then be followed for 2 years for the signs and symptoms of atopic dermatitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emollient | Experimental | Drug: emollient (Cetaphil cream)Skin barrier protection from birth |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- at least one parent diagnosed with Atopic Dermatitis
- one parent or sibling with hayfever or asthma
Key exclusion criteria (4 listed)
- newborns with dermatitis at birth
- newborns born greater than four weeks prematurely
- newborns with medical problems necessitating prolonged hospitalization
- newborns diagnosed with any immune deficiency syndrome
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 |
|---|---|---|
| emollient (Cetaphil cream)Cetaphil cream applied daily from birth | Drug | Emollient |
Primary outcome
Incidence of Skin Irritation
Time frame: 1 and 2 year time points
Incidence of Skin Infection
Time frame: 1 and 2 year timepoints
Compliance With Protocol
Time frame: over two years
1 secondary outcome
Development of Eczema
Time frame: 1 and 2 year time points
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 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 Phase 2 study testing emollient (Cetaphil cream) in people with Atopic Dermatitis, 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 2 inclusion and 4 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 Jul 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Skin Irritation (time frame: 1 and 2 year time points). The study lists 3 primary outcomes in all. 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 Jul 2017.