Proof of Concept Investigation of the Steroid-reducing Effects of Crisaborole in Children

IRB00178631

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.

2019-12-17

2024-12-01

2024-12-01

Active (not recruiting)

Early phase I

24

Inclusion criteria: * 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). Exclusion criteria: * Known allergy to a constituent of the studied products (crisaborole, vehicle, Aquaphor, topical steroids \[hydrocortisone 2.5% ointment and triamcinolone acetonide 0.1% ointment\]). * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2023-12-18