Clinical trial NCT03832010: Steroid-reducing Effects of Crisaborole
Official title: Proof of Concept Investigation of the Steroid-reducing Effects of Crisaborole in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Eczema
Keywords: Topical steroid
Crisaborole
Topical calcineurin inhibitor
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2019-02-06
Enrollment: 24
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Steroid Usage Quantity
timeFrame: Day 30
measure: Steroid Usage Quantity
timeFrame: Day 90
measure: Steroid Usage Frequency
timeFrame: Day 30
measure: Steroid Usage Frequency
timeFrame: Day 90
Secondary outcomes:
measure: Eczema Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Score
timeFrame: Day 0
measure: Eczema Severity Assessed by SCORAD Score
timeFrame: Day 30
measure: Eczema Severity Assessed by SCORAD Score
timeFrame: Day 90
measure: Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
timeFrame: Day 0
measure: Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
timeFrame: Day 30
measure: Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
timeFrame: Day 90
measure: Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
timeFrame: Day 0
measure: Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
timeFrame: Day 30
measure: Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
timeFrame: Day 90
measure: Severity of Itching as Assessed by Pruritus Score
timeFrame: Day 0
measure: Severity of Itching as Assessed by Pruritus Score
timeFrame: Day 30
measure: Severity of Itching as Assessed by Pruritus Score
timeFrame: Day 90
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Anna Grossberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paller AS, Tom WL, Lebwohl MG, Blumenthal RL, Boguniewicz M, Call RS, Eichenfield LF, Forsha DW, Rees WC, Simpson EL, Spellman MC, Stein Gold LF, Zaenglein AL, Hughes MH, Zane LT, Hebert AA. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016 Sep;75(3):494-503.e6. doi: 10.1016/j.jaad.2016.05.046. Epub 2016 Jul 11.
citation: Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.