Steroid-reducing Effects of Crisaborole

Johns Hopkins University

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis; Eczema

Treatments: Drug: Aquaphor; Drug: Crisaborole; Drug: Triamcinolone ointment; Drug: Hydrocortisone Ointment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03832010

IRB00178631

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 3 patient groups, including a placebo group

Crisaborole

Active Comparator group

Description:

Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.

Treatment:

Drug: Hydrocortisone Ointment

Drug: Triamcinolone ointment

Drug: Aquaphor

Drug: Crisaborole

Vehicle

Placebo Comparator group

Description:

Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.

Treatment:

Drug: Hydrocortisone Ointment

Drug: Triamcinolone ointment

Drug: Aquaphor

Control

Sham Comparator group

Description:

Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.

Treatment:

Drug: Hydrocortisone Ointment

Drug: Triamcinolone ointment

Drug: Aquaphor