NCT03832010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

December 17, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2024

Completed
5 months until next milestone

Results Posted

Study results publicly available

July 19, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

4.2 years

First QC Date

January 25, 2019

Results QC Date

June 25, 2024

Last Update Submit

July 17, 2024

Conditions

Atopic DermatitisEczema

Keywords

Topical steroidCrisaboroleTopical calcineurin inhibitor

Outcome Measures

Primary Outcomes (4)

  • 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. Weekly average frequency of steroid use is reported.

    Day 30

  • Steroid Usage Frequency

    Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported.

    Day 90

Secondary Outcomes (12)

  • Eczema Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Score

    Day 0

  • Eczema Severity Assessed by SCORAD Score

    Day 30

  • Eczema Severity Assessed by SCORAD Score

    Day 90

  • Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index

    Day 0

  • Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index

    Day 30

  • +7 more secondary outcomes

Study Arms (3)

Crisaborole

ACTIVE COMPARATOR

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

Drug: CrisaboroleDrug: Hydrocortisone OintmentDrug: Triamcinolone ointmentDrug: Aquaphor

Vehicle

PLACEBO COMPARATOR

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

Drug: Hydrocortisone OintmentDrug: Triamcinolone ointmentDrug: Aquaphor

Control

SHAM COMPARATOR

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

Drug: Hydrocortisone OintmentDrug: Triamcinolone ointmentDrug: Aquaphor

Interventions

CrisaboroleDRUG

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

Also known as: Eucrisa
Crisaborole
Hydrocortisone OintmentDRUG

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

ControlCrisaboroleVehicle
Triamcinolone ointmentDRUG

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

ControlCrisaboroleVehicle
AquaphorDRUG

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

ControlCrisaboroleVehicle

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

  • 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.

    PMID: 27417017BACKGROUND

  • 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.

    PMID: 24813302BACKGROUND

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Interventions

crisaborolePetrolatum

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

HydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Ruizhi Wang
Organization
Cutaneous Translational Research Program
rwang@jhmi.edu
4105027546

Study Officials

  • Anna Grossberg, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

February 6, 2019

Study Start

December 17, 2019

Primary Completion

February 16, 2024

Study Completion

February 16, 2024

Last Updated

July 19, 2024

Results First Posted

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)