NMF-CsA-Dupi Trial

  • STATUS
    Recruiting
  • End date
    Jan 1, 2025
  • participants needed
    318
  • sponsor
    Erasmus Medical Center
Updated on 26 August 2021
corticosteroids
cyclosporine
eczema
topical corticosteroid
dupilumab
topical agents
high potency

Summary

The goal of this study is to investigate whether stratification of children with atopic dermatitis on the NMF biomarkers results in an improvement of effectiveness and efficiency in the use of systemic treatment (ciclosporin and dupilumab) in moderate-to-severe atopic dermatitis.

Details
Condition Dermatite Atopique, Dermatitis, Atopic, Eczema (Atopic Dermatitis), Eczéma (Dermatite Atopique), ATOPIC DERMATITIS, Atopic Dermatitis
Treatment Topical corticosteroids, Systemic cyclosporine, Systemic dupilumab
Clinical Study IdentifierNCT04878770
SponsorErasmus Medical Center
Last Modified on26 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Children and adolescents, aged 2-18 years, with moderate-to-severe atopic dermatitis (diagnosed according to the UK working party criteria)
Patient and parents/guardians able to participate in the study and willing to give written informed consent
EASI (Eczema Area Severity Index) 6 at screening and baseline (corresponding with moderate-to-severe disease)
IGA (Investigator Global Assessment) 3 at screening and baseline (corresponding with moderate-to-severe disease)

Exclusion Criteria

Children under the age of 2 years and patients older than 18 years
Contraindication for ciclosporin
Contraindication for dupilumab
Patient (or one of the parents/guardians) not willing to be randomized
Children with a history of any known primary immunodeficiency disorder
Children with a history of cancer
EASI < 6 at screening or baseline
IGA < 3 at screening or baseline
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