Seal, Stopping Eczema and Allergy Study

  • STATUS
    Recruiting
  • End date
    Jul 16, 2027
  • participants needed
    875
  • sponsor
    Kari Christine Nadeau, MD, PhD
Updated on 16 May 2022
food allergy
eczema
dry skin
topical agents
epiceram

Summary

This is a randomized, controlled trial designed for children who are have already developed atopic dermatitis (AD or eczema) by 12 weeks of age. The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) or moisturizer and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).

Description

This is a randomized, controlled, parallel design, open-label phase 2 clinical study to compare the efficacy of the two proactive treatment arms versus the reactive arm, for the prevention of atopic dermatitis in children at high risk of food allergy. We will recruit 875 infants who have signs of dry skin or atopic dermatitis between 0-12 weeks of life.

The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) or moisturizer and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).

Details
Condition Eczema, Infantile, Eczema, Atopic Dermatitis Eczema, Atopic Dermatitis
Treatment Standard of Care, Moisturizer, Tri-lipid skin barrier cream (Epiceram), Fluticasone propionate Cream 0.05%
Clinical Study IdentifierNCT03742414
SponsorKari Christine Nadeau, MD, PhD
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants who develop early onset visible dry skin or atopic dermatitis up to and equal to 12 weeks of age
Stated willingness to comply with all study procedures and availability for the duration of the study
In good general health as evidenced by medical history
No known adverse reaction to any of the study medications, their components or excipients

Exclusion Criteria

Infants <3kg body weight
Infants with a chronic disease requiring therapy (e.g. heart disease, diabetes, serious neurological defects, immunodeficiency)
Known moderate to severe cutaneous skin disorder other than AD, including but not limited to cutaneous mastocytosis, bullous skin disease, pustular skin disease, neonatal HSV, aplasia, and albinism
Parents or guardians unwilling to sign consent
Current participant or participation since birth in any interventional study
Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study (for ex/ long stay in NICU)
A course of antibiotics in infant within 7 days of enrollment
Any known food allergies
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note