Steroid-reducing Effects of Crisaborole

  • STATUS
    Recruiting
  • End date
    Dec 14, 2024
  • participants needed
    60
  • sponsor
    Johns Hopkins University
Updated on 14 July 2022
skin disorder
triamcinolone
atopy
eczema
crisaborole
topical agents
Accepts healthy volunteers

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 research study seeks to investigate whether crisaborole reduces topical steroid use in children with atopic dermatitis.

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. Side effects of TCS range from cutaneous atrophy to hypothalamic-pituitary-adrenal axis suppression. Steroid phobia and misunderstanding often lead to poor compliance and inadequate disease control. Topical calcineurin inhibitors (TCIs) are currently recommended as steroid-reducing agents, especially on sensitive areas such as the face and skin folds. However, TCis are associated with burning reactions and come with black box warnings.

Crisaborole (Eucrisa), the newest topical prescription option for AD, is a phosphodiesterase-4 inhibitor with demonstrated efficacy in patients aged 2 and older with mild to moderate AD. Given the good tolerability and favorable safety profile, crisaborole makes for an alternative topical option to its predecessors. However, corresponding data are lacking. It would be of great interest to patients, patients' families and providers if crisaborole can be shown to reduce the amount of TCS necessary for control of AD. The investigators therefore propose a proof-of-concept study to investigate whether crisaborole can serve as an effective steroid-reducing agent.

Details
Condition Atopic Dermatitis, Eczema
Treatment Crisaborole, Hydrocortisone Ointment, Triamcinolone ointment, Aquaphor
Clinical Study IdentifierNCT03832010
SponsorJohns Hopkins University
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

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
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