Status:
COMPLETED
Steroid-reducing Effects of Crisaborole
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Pfizer
Conditions:
Atopic Dermatitis
Eczema
Eligibility:
All Genders
2-17 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
Atopic dermatitis (AD) is a chronic skin disease and a common affliction among children. Twice daily topical corticosteroid (TCS) use over several weeks is recommended for active inflammatory disease....
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03832010
Start Date
December 17 2019
End Date
February 16 2024
Last Update
July 19 2024
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287