Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

Atopic Dermatitis Clinical Trial

Official title:

Monitoring Response to Therapy in Atopic Dermatitis Patients Treated With Dupilumab Using Noninvasive Reflectance Confocal Microscopy and Optical Coherence Tomography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05265234
• Other study ID #: OPTI-003
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: February 2022
• Source: OptiSkin Medical
• Contact: Moshe Bressler, DO
• Phone: 212-828-3120
• Email: moshe[@]optiskinmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)?"

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Dupilumab
IL-4 antagonist to improve moderate-severe atopic dermatitis

Device:
• Optical Coherence Tomography
OCT is a noninvasive imaging device that can be used to monitor inflammatory skin disorders.
• Reflectance confocal microscopy
RCM is a noninvasive imaging device, with resolution approaching that of histology, which can monitor structural changes in the epidermis and superficial dermis, monitor inflammatory cells, and can overcome the limitations of a traditional biopsy.

Locations

Country	Name	City	State
United States	OptiSkin Medical	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
OptiSkin Medical	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (5)

Byers RA, Maiti R, Danby SG, Pang EJ, Mitchell B, Carré 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. — View 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. Review. — View 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. — View 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. Epub 2016 Sep 30. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eczema Area and Severity Index (EASI)	The Eczema Area and Severity Index (EASI) is a tool used to measure the extent (area) and severity of atopic eczema, ranging 0-72, 0 being least severe and 72 being most severe.	Baseline to 16 weeks
Primary	Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD)	Investigator will use the Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) a tool used to measure the severity of atopic eczema, ranging 0-4, 0 is clear and 4 is most severe.	Baseline to 16 weeks
Primary	Noninvasive Imaging (clinical response) with Reflectance Confocal Microscopy (RCM)	Reflectance Confocal Microscopy (RCM) is a noninvasive imaging device that can be used to monitor the severity of inflammatory skin disorders without the need for a biopsy. RCM can visualize cells with a resolution comparable to a light microscope, allowing the investigators to identify the degree of inflammation and damage to the skin.; An overall disease severity score ranging from 0-3 (0=none, 1=mild, 2= moderate, 3=severe) will use aggregates of the following *features: Spongiosis; Parakeratosis; Epidermal thickness; Quality of honeycomb structure of the stratum spinosum; Appearance of the dermal-epidermal junction; Appearance of the superficial dermis; Recognition of the dermal papilla; Caliber of blood vessels; Presence of inflammatory cells; Grading will be scored (0=none, 1=mild, 2= moderate, 3=severe), a greater numerical score indicates more advanced disease.	Baseline to 16 weeks
Primary	Noninvasive Imaging (clinical response) with Optical Coherence Tomography (OCT)	Optical Coherence Tomography (OCT) is a noninvasive imaging device that can be used to monitor the severity of inflammatory skin disorders without the need for a biopsy. OCT can detect deep structures in the skin, identify areas of inflammation, and determine the thickness of the skin. These measures will be consolidated to a severity score ranging 0-3, (0= no disease, 3= severe disease) and will be tracked throughout the duration of the study.; The following features will be aggregated to form an Optical Coherence Tomography-severity-score: Change in the epidermal thickness; Changes in anatomy or appearance of the dermo-epidermal junction and the dermis.; Changes in vascular flow patterns, including the number and density of vessels in skin using the dynamic feature of Optical Coherence Tomography; Grading will be scored 0=none, 1=mild, 2= moderate, 3=severe	Baseline to 16 weeks

External Links

•   FDA Approved Drugs: Dupixent