Steroid-reducing Effects of Crisaborole

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Atopic Dermatitis, Eczema

Intervention / Treatment
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* Drug: Crisaborole
* Drug: Hydrocortisone Ointment
* Drug: Triamcinolone ointment
* Drug: Aquaphor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Crisaborole<br>Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema. | Drug: Crisaborole<br>* Participants will be instructed to apply crisaborole to affected areas with eczema.<br>* Other names: Eucrisa;Drug: Hydrocortisone Ointment<br>* Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.<br>Drug: Triamcinolone ointment<br>* Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.<br>Drug: Aquaphor<br>* Participants will be instructed to moisturize all over the body with Aquaphor.<br>|
| Placebo Comparator: Vehicle<br>Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema. | Drug: Hydrocortisone Ointment<br>* Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.<br>Drug: Triamcinolone ointment<br>* Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.<br>Drug: Aquaphor<br>* Participants will be instructed to moisturize all over the body with Aquaphor.<br>|
| Sham Comparator: Control<br>Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema. | Drug: Hydrocortisone Ointment<br>* Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.<br>Drug: Triamcinolone ointment<br>* Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.<br>Drug: Aquaphor<br>* Participants will be instructed to moisturize all over the body with Aquaphor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steroid usage quantity | Steroid usage measured in medication weight (grams) | Day 30 | 
| Steroid usage quantity | Steroid usage measured in medication weight (grams) | Day 90 | 
| Steroid usage frequency | Steroid usage measured in diary entries | Day 30 | 
| Steroid usage frequency | Steroid usage measured in diary entries | Day 90 | 
| Steroid refills | Steroid usage measured in number of refills | Day 30 | 
| Steroid refills | Steroid usage measured in number of refills | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Day 90 | 
| Quality of life for participant as assessed by Children's Dermatology Life Quality Index | 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. | Day 0 | 
| Quality of life for participant as assessed by Dermatology Life Quality Index | Dermatology Life Quality Index (ages 16 or older). 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. | Day 0 | 
| Quality of life for participant as assessed by Children's Dermatology Life Quality Index | 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. | Day 30 | 
| Quality of life for participant as assessed by Dermatology Life Quality Index | Dermatology Life Quality Index (ages 16 or older). 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. | Day 30 | 
| Quality of life for participant as assessed by Children's Dermatology Life Quality Index | 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. | Day 90 | 
| Quality of life for participant as assessed by Dermatology Life Quality Index | Dermatology Life Quality Index (ages 16 or older). 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. | Day 90 | 
| Quality of life for family as assessed by Dermatitis Family Impact Questionnaire | 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. | Day 0 | 
| Quality of life for family as assessed by Dermatitis Family Impact Questionnaire | 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. | Day 30 | 
| Quality of life for family as assessed by Dermatitis Family Impact Questionnaire | 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. | Day 90 | 
| Severity of itching as assessed by Pruritus score | 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. | Day 0 | 
| Severity of itching as assessed by Pruritus score | 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. | Day 30 | 
| Severity of itching as assessed by Pruritus score | 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. | Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Topical steroid, Crisaborole, Topical calcineurin inhibitor