Steroid-reducing Effects of Crisaborole

Phase 4CompletedNCT03832010

Johns Hopkins University24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Atopic Dermatitis Eczema

Interventions

CrisaboroleDRUG

Participants will be instructed to apply crisaborole to affected areas with eczema.

Hydrocortisone OintmentDRUG

Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.

Triamcinolone ointmentDRUG

Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Steroid Usage Quantity

Steroid usage measured in medication weight (grams)

Time frame: Day 30

Steroid Usage Quantity

Steroid usage measured in medication weight (grams)

Time frame: Day 90

Steroid Usage Frequency

Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported.

Time frame: Day 30

Steroid Usage Frequency

Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported.

Time frame: Day 90

Secondary Outcomes

Eczema Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Score

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.

Time frame: Day 0

Eczema Severity Assessed by SCORAD Score

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.

Time frame: Day 30

Eczema Severity Assessed by SCORAD Score

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.

Time frame: Day 90

Data from ClinicalTrials.gov

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