A Phase 2 interventional study of emollient (Cetaphil cream) in Atopic Dermatitis, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged Up to 1 Month. Per ClinicalTrials.gov, last updated 2017-07-11.
Sponsored by Oregon Health and Science University · Phase 2, Interventional, and Prevention
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.
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 22 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Skin barrier protection from birth
Drug: emollient (Cetaphil cream)
Cetaphil cream applied daily from birth
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
Development of Eczema
Time frame: 1 and 2 year time points
| Milestone | Emollient |
|---|---|
| Started | 22 |
| Completed | 20 |
| Not completed | 2 |
| Participants | Emollient |
|---|---|
| Incidence of Skin Irritation | 0 |
| Participants | Emollient |
|---|---|
| Incidence of Skin Infection | 0 |
| participants | Emollient |
|---|---|
| Compliance With Protocol | 20 |
| Participants | Emollient |
|---|---|
| Development of Eczema | 5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Emollient | — | 0/22 (0%) | 0/22 (0%) |
| Age, Categorical(Participants) | Emollient |
|---|---|
| <=18 years | 22 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex/Gender, Customized(participants) | Emollient |
|---|---|
| gender/sex was not recorded | 22 |
| Race/Ethnicity, Customized(Participants) | Emollient |
|---|---|
| non-Hispanic Caucasian | 16 |
| Hispanic Caucasian | 2 |
| Asian | 2 |
| African American | 2 |
| Region of Enrollment(participants) | Emollient |
|---|---|
| United States | 22 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oregon Health and Science University