Atopic Dermatitis Clinical Trial
Official title:
PDE4A Expression as a Biomarker of Responsiveness to Eucrisa
Verified date | July 2022 |
Source | Ann & Robert H Lurie Children's Hospital of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 11, 2022 |
Est. primary completion date | February 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Months to 17 Years |
Eligibility | Inclusion Criteria: - AD diagnosis by dermatologist or allergist based on Hanifin and Rajka criteria - 5% 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Ann & Robert H Lurie Children's Hospital of Chicago | Pfizer |
United States,
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. — View Citation
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. — View Citation
Hamilton JD, Suárez-Fariñas 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. — 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
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | Changes in quality of life will be measured by comparing standardized PROMIS T-scores for each domain at Day 28 with baseline. The PROMIS Pediatric Profile 25 is a 25-item questionnaire and assesses anxiety, depressive symptoms, fatigue, mobility, pain interference, and peer relationships. Each item has five response options. The HealthMeasures Scoring Service will be used to calculate T-scores for each domain. A T-score of 50 is the average for the United States general population with a standard deviation of 10. A higher T-score represents more of the concept being measured. Responsiveness will be determined by comparing clinician-assessed disease severity by ISGA and EASI scores at baseline and Day 28. | Baseline (Day 1) and Day 28 | |
Secondary | 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 | Changes in quality of life will be measured by comparing CDLQI scores at Day 28 with baseline. The CDLQI is a 10-item questionnaire assessing symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. Scores range from 0 to 30 and are calculated by summing the scores of each question. The higher the score, the more impaired quality of life. Responsiveness will be determined by comparing ISGA and EASI scores at baseline and Day 28. | Baseline (Day 1) and Day 28 | |
Secondary | Correlation of TEWL with clinical responsiveness and biomarker PDE4A expression levels | Diffusion of water through the skin is measured using the AquaFlux instrument. Responsiveness will be determined by comparing ISGA and EASI scores at baseline and Day 28. | Baseline (Day 1) and Day 28 |
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