Clinical trial NCT05265234: Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.
Official title: Monitoring Response to Therapy in Atopic Dermatitis Patients Treated With Dupilumab Using Noninvasive Reflectance Confocal Microscopy and Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Eczema
Atopic Dermatitis
Keywords: dermatitis
Dupilumab
Inflammatory Skin Diseases
itch relief
biologic
Lead sponsor: OptiSkin Medical
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2022-03-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief summary: The study is trying to answer the following question: "Can we use non-invasive imaging to evaluate the response of atopic dermatitis (eczema) to Dupixent (dupilumab)?"

Detailed description: Participating in this research will allow the subject to undergo a noninvasive imaging alternative to conventional monitoring in response to a biologic. Normally, subjects would undergo a clinical examination, serial photography, and possible biopsies to assess the progression of the disease. This study will get rid of the need for a biopsy but will require multiple scans with non-invasive imaging. This research examines a new approach to monitoring response to a biologic drug used for atopic dermatitis, and can also, be used to grade disease severity without the need for a biopsy.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Atopic dermatitis (AD) affecting ≥10% body surface area (BSA) at baseline
* IGA score ≥3, on the IGA scale of 0-4 at baseline
* Eczema Area and Severity Index (EASI) score of ≥16 at baseline

Exclusion Criteria:

* Prior treatment with Dupilumab (REGN668/SAR231893)
* Treatment with TCS or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline visit
* Bodyweight \<30 kg (65lb) at Baseline
* Known or suspected immunodeficiency including human immunodeficiency virus (HIV) infection
* Pregnancy, breastfeeding or planning to become pregnant or breastfeed during the study

Primary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: Baseline to 16 weeks
measure: Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD)
timeFrame: Baseline to 16 weeks
measure: Noninvasive Imaging (clinical response) with Reflectance Confocal Microscopy (RCM)
timeFrame: Baseline to 16 weeks
measure: Noninvasive Imaging (clinical response) with Optical Coherence Tomography (OCT)
timeFrame: Baseline to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: OptiSkin Medical
state: New York
Study officials:
affiliation: Medical Director
name: Orit Markowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leung DY, Guttman-Yassky E. Deciphering the complexities of atopic dermatitis: shifting paradigms in treatment approaches. J Allergy Clin Immunol. 2014 Oct;134(4):769-79. doi: 10.1016/j.jaci.2014.08.008.
citation: Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, Blauvelt A, Cork MJ, Silverberg JI, Deleuran M, Kataoka Y, Lacour JP, Kingo K, Worm M, Poulin Y, Wollenberg A, Soo Y, Graham NM, Pirozzi G, Akinlade B, Staudinger H, Mastey V, Eckert L, Gadkari A, Stahl N, Yancopoulos GD, Ardeleanu M; SOLO 1 and SOLO 2 Investigators. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016 Dec 15;375(24):2335-2348. doi: 10.1056/NEJMoa1610020. Epub 2016 Sep 30.
citation: Meinke MC, Richter H, Kleemann A, Lademann J, Tscherch K, Rohn S, Schempp CM. Characterization of atopic skin and the effect of a hyperforin-rich cream by laser scanning microscopy. J Biomed Opt. 2015 May;20(5):051013. doi: 10.1117/1.JBO.20.5.051013.
citation: Byers RA, Maiti R, Danby SG, Pang EJ, Mitchell B, Carre MJ, Lewis R, Cork MJ, Matcher SJ. Sub-clinical assessment of atopic dermatitis severity using angiographic optical coherence tomography. Biomed Opt Express. 2018 Mar 29;9(4):2001-2017. doi: 10.1364/BOE.9.002001. eCollection 2018 Apr 1.
citation: Tang TS, Bieber T, Williams HC. Are the concepts of induction of remission and treatment of subclinical inflammation in atopic dermatitis clinically useful? J Allergy Clin Immunol. 2014 Jun;133(6):1615-25.e1. doi: 10.1016/j.jaci.2013.12.1079. Epub 2014 Mar 18.