Steroid-reducing Effects of Crisaborole

NCT ID: NCT03832010

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-17
• Study Completion Date: 2024-02-16

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.

Conditions

Atopic Dermatitis; Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Crisaborole

Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.

Group Type: ACTIVE_COMPARATOR

Crisaborole

Intervention Type: DRUG

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

Hydrocortisone Ointment

Intervention Type: DRUG

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

Triamcinolone ointment

Intervention Type: DRUG

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

Aquaphor

Intervention Type: DRUG

Participants will be instructed to moisturize all over the body with Aquaphor.

Vehicle

Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.

Group Type: PLACEBO_COMPARATOR

Hydrocortisone Ointment

Intervention Type: DRUG

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

Triamcinolone ointment

Intervention Type: DRUG

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

Aquaphor

Intervention Type: DRUG

Participants will be instructed to moisturize all over the body with Aquaphor.

Control

Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.

Group Type: SHAM_COMPARATOR

Hydrocortisone Ointment

Intervention Type: DRUG

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

Triamcinolone ointment

Intervention Type: DRUG

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

Aquaphor

Intervention Type: DRUG

Participants will be instructed to moisturize all over the body with Aquaphor.

Interventions

Crisaborole

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

Intervention Type: DRUG

Hydrocortisone Ointment

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

Intervention Type: DRUG

Triamcinolone ointment

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

Intervention Type: DRUG

Aquaphor

Participants will be instructed to moisturize all over the body with Aquaphor.

Intervention Type: DRUG

Other Intervention Names

Eucrisa

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Grossberg, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27417017 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24813302 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00178631

Identifier Type: -

Identifier Source: org_study_id