Steroid-reducing Effects of Crisaborole

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03832010
• Other study ID #: IRB00178631
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 17, 2019
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Eczema

Intervention

Drug:
• Crisaborole
Participants will be instructed to apply crisaborole to affected areas with eczema.
• Hydrocortisone Ointment
Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.
• Triamcinolone ointment
Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.
• Aquaphor
Participants will be instructed to moisturize all over the body with Aquaphor.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steroid usage quantity	Steroid usage measured in medication weight (grams)	Day 30
Primary	Steroid usage quantity	Steroid usage measured in medication weight (grams)	Day 90
Primary	Steroid usage frequency	Steroid usage measured in diary entries	Day 30
Primary	Steroid usage frequency	Steroid usage measured in diary entries	Day 90
Primary	Steroid refills	Steroid usage measured in number of refills	Day 30
Primary	Steroid refills	Steroid usage measured in number of refills	Day 90
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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