Steroid-reducing Effects of Crisaborole

Phase 4

Completed

Conditions: Atopic Dermatitis
Eczema

Interventions: Drug: Crisaborole
Drug: Hydrocortisone Ointment
Drug: Triamcinolone ointment
Drug: Aquaphor

Registration Number: NCT03832010

Lead Sponsor: Johns Hopkins University

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crisaborole	Triamcinolone ointment	Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.
Crisaborole	Crisaborole	Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.
Crisaborole	Aquaphor	Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.
Vehicle	Hydrocortisone Ointment	Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.
Vehicle	Triamcinolone ointment	Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.
Vehicle	Aquaphor	Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.
Control	Hydrocortisone Ointment	Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.
Control	Aquaphor	Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.
Control	Triamcinolone ointment	Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.
Crisaborole	Hydrocortisone Ointment	Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.

Primary Outcome Measures

Name	Time	Method
Steroid Usage Quantity	Day 90	Steroid usage measured in medication weight (grams)
Steroid Usage Frequency	Day 90	Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported.

Secondary Outcome Measures

Name	Time	Method
Severity of Itching as Assessed by Pruritus Score	Day 90	Pruritus score determined using Numerical Rating Scale. Minimum score is 0. Maximum score is 10. Lowest score means no itching. Highest score corresponds to the most severe itching imaginable by patient.
Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index	Day 90	Children's Dermatology Life Quality Index (ages 15 or younger). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire	Day 90	Dermatitis Family Impact Questionnaire. Minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
Eczema Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Score	Day 0	Clinical assessment using SCORAD score: minimum score = 0, maximum score = 103. Highest score corresponds with highest severity of eczema. Lowest score corresponds with lowest severity of eczema.
Eczema Severity Assessed by SCORAD Score	Day 90	Clinical assessment using SCORAD score: minimum score = 0, maximum score = 103. Higher score corresponds with increased severity of eczema. Lowest score corresponds with lowest severity of eczema.