Response of Children With Atopic Dermatitis (Eczema) to Eucrisa

NCT04023084 | Completed Phase 4 FDA Drug

• 1 other identifier: 2019-2879
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop biomarkers to predict what medication is best for each child with atopic dermatitis (eczema). Participants will come in to Lurie Children's Allergy of Dermatology clinic for a skin examination and complete surveys. They will apply Eucrisa medication to their skin for 28 days before returning for a second and final skin examination and complete surveys. During these skin exams, tape will be placed on the skin and removed to collect skin cell samples. Photos will also be taken of the skin where tape was placed. There is an optional blood draw.

Conditions

Atopic Dermatitis; Eczema

Keywords

dermatologic agents; surveys; questionnaires; topical therapy

Outcome Measures

Primary Outcomes (1)

• Changes in expression levels of biomarkers in responder versus non responder groups

  The baseline mean expression levels of biomarkers extracted from tape strips (TH2 (IL13, IL4R, CCL26), TH17/22 (IL36G), itch (ENKUR), epidermal genes (FLG, LOR and S100A9) and PDE4A will be compared in clinical "responder" versus "non-responder" groups. Groups will be defined by the primary clinical outcome of disease severity improvement by clinician assessment. Clinicians will assess disease severity by Investigator's Static Global Assessment (ISGA) and Eczema Area and Severity Index (EASI) score.

  Baseline (Day 1) and Day 28

Secondary Outcomes (3)

• Changes in Quality of life (anxiety, depressive symptoms, fatigue, mobility, pain interference, peer relationships) as assessed by PROMIS Pediatric Profile 25 and Correlation of changes with clinical responsiveness and biomarker PDE4A expression levels

  Baseline (Day 1) and Day 28

• Changes in Quality of life (symptoms and feelings, leisure, school or holidays, personal relationships, sleep, treatment) as assessed by CDLQI and Correlation of Quality of life changes with clinical responsiveness and biomarker PDE4A expression levels

  Baseline (Day 1) and Day 28

• Correlation of TEWL with clinical responsiveness and biomarker PDE4A expression levels

  Baseline (Day 1) and Day 28

Study Arms (1)

Atopic Dermatitis Group

EXPERIMENTAL

Receive crisaborole intervention

Drug: Crisaborole

Interventions

Crisaborole DRUG

Crisaborole 2% topical ointment applied twice daily to affected area(s) for 28 days

Also known as: Eucrisa

Atopic Dermatitis Group

Eligibility Criteria

• Age: 4 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• AD diagnosis by dermatologist or allergist based on Hanifin and Rajka criteria
• % or more treatable body surface area involvement
• baseline Investigator's Static Assessment (ISGA) score of mild (2) or moderate (3)
• patient on stable regimens (consistent use 14 days before day 1 of enrollment) of inhaled corticosteroids and antihistamines
• must have lesional skin in the antecubital fossa

You may not qualify if:

• use of topical corticosteroid, calcineurin inhibitor, or PDE4 inhibitor within 14 days of enrollment
• significant active infection
• any previous use of biologic therapy
• no pruritus at baseline visit, or other pruritic condition
• washing/moisturizer use 24 hours prior to tape strip biomarker collection at site
• uncontrolled asthma, uncontrolled allergic rhinitis, or other sleep disturbing condition

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Pfizer: collaborator

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

• Dyjack N, Goleva E, Rios C, Kim BE, Bin L, Taylor P, Bronchick C, Hall CF, Richers BN, Seibold MA, Leung DYM. Minimally invasive skin tape strip RNA sequencing identifies novel characteristics of the type 2-high atopic dermatitis disease endotype. J Allergy Clin Immunol. 2018 Apr;141(4):1298-1309. doi: 10.1016/j.jaci.2017.10.046. Epub 2018 Jan 6.

  PMID: 29309794 BACKGROUND

• 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: 27417017 BACKGROUND

• Paton DM. Crisaborole: Phosphodiesterase inhibitor for treatment of atopic dermatitis. Drugs Today (Barc). 2017 Apr;53(4):239-245. doi: 10.1358/dot.2017.53.4.2604174.

  PMID: 28492291 BACKGROUND

• Hamilton JD, Suarez-Farinas M, Dhingra N, Cardinale I, Li X, Kostic A, Ming JE, Radin AR, Krueger JG, Graham N, Yancopoulos GD, Pirozzi G, Guttman-Yassky E. Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2014 Dec;134(6):1293-1300. doi: 10.1016/j.jaci.2014.10.013.

  PMID: 25482871 BACKGROUND

• Simpson EL, Paller AS, Boguniewicz M, Eichenfield LF, Feldman SR, Silverberg JI, Chamlin SL, Zane LT. Crisaborole Ointment Improves Quality of Life of Patients with Mild to Moderate Atopic Dermatitis and Their Families. Dermatol Ther (Heidelb). 2018 Dec;8(4):605-619. doi: 10.1007/s13555-018-0263-0. Epub 2018 Oct 22.

  PMID: 30345457 BACKGROUND

• Chamlin SL, Mattson CL, Frieden IJ, Williams ML, Mancini AJ, Cella D, Chren MM. The price of pruritus: sleep disturbance and cosleeping in atopic dermatitis. Arch Pediatr Adolesc Med. 2005 Aug;159(8):745-50. doi: 10.1001/archpedi.159.8.745.

  PMID: 16061782 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

crisaborole

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Anna Fishbein, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Allergy & Immunology

Model Details: children diagnosed with AD and aged 4 months-17 years old will receive intervention

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 17, 2019
• Study Start: October 3, 2019
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available after primary publication is accepted.
• Access Criteria: Individual participant data will be publicly available through journal publication.

Locations

US (1)