NCT03832010

Steroid-reducing Effects of Crisaborole

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

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.

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. 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.

Conditions

• Atopic Dermatitis
• Eczema

Interventions

Type	Name	Description
DRUG	Crisaborole	Participants will be instructed to apply crisaborole to affected areas with eczema.
DRUG	Hydrocortisone Ointment	Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.
DRUG	Triamcinolone ointment	Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.
DRUG	Aquaphor	Participants will be instructed to moisturize all over the body with Aquaphor.

Timeline

• Start date: 2019-12-17
• Primary completion: 2024-02-16
• Completion: 2024-02-16
• First posted: 2019-02-06
• Last updated: 2024-07-19
• Results posted: 2024-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study