Steroid-reducing Effects of Crisaborole

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Eczema; Atopic Dermatitis
• Intervention / Treatment: Drug: Crisaborole; Drug: Hydrocortisone Ointment; Drug: Triamcinolone ointment; Drug: Aquaphor

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ruizhi Wang; Phone Number: 410-502-7546; Email: rwang@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Pfizer
• Investigators: Principal Investigator: Anna Grossberg, MD, Johns Hopkins University

Publications and helpful links

General Publications

• 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. Erratum In: J Am Acad Dermatol. 2017 Apr;76(4):777.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Topical steroid; Crisaborole; Topical calcineurin inhibitor
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Hydrocortisone
• Other Study ID Numbers: IRB00178631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No