NCT03832010CompletedPhase 4
Steroid-reducing Effects of Crisaborole
Proof of Concept Investigation of the Steroid-reducing Effects of Crisaborole in Children
Source: ClinicalTrials.gov · Last updated 19 Jul 2024
Brief summary (registry, in English)
Atopic dermatitis, or eczema, is a chronic skin condition affecting many children. Crisaborole is a non-steroid topical medication which is FDA approved for children aged 2 and older for eczema. This research study seeks to investigate whether crisaborole reduces topical steroid use in children with atopic dermatitis.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 25 Jan 2019
- Start date
- 17 Dec 2019
- Primary completion date
- 16 Feb 2024
- Lead sponsor
- Johns Hopkins University
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT03832010
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 24
- From 17 Dec 2019 to the primary completion date, 16 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergy to a constituent of the studied products (crisaborole, vehicle, Aquaphor, topical steroids \[hydrocortisone 2.5% ointment and triamcinolone acetonide 0.1% ointment\]).
Other
- At baseline, AD is severe (score of 4 \[severe\] on the IGA scale).
- Medical problems which interfere with completion of protocols in this study.
- Pregnant or lactating females. (Females who have experienced menarche will be required to take a urine pregnancy test.)
- Participant is enrolled in another research study.
- Participant or participant's guardian(s) are unable to follow instructions as required in this study.
Who the study is looking for
- Children aged 2 or older (\<18).
- Diagnosed with atopic dermatitis.
- At baseline, AD is mild to moderate (score of 2 \[mild\] to 3 \[moderate\]) on the Investigator's Global Assessment scale (IGA; scores range 0-4, higher indicates greater severity).
Age in the registry: 2 years to 17 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.