EczemaPhase 4NCT05265234
Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.
A Phase 4 study testing Dupilumab, Optical Coherence Tomography and Reflectance confocal microscopy in people with Eczema and Atopic Dermatitis, run by OptiSkin Medical at 1 site in United States.
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)?" Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eczema, Atopic Dermatitis
- What is being tested?
- Dupilumab, Optical Coherence Tomography and Reflectance confocal microscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 1 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
OptiSkin Medical
New York, New York, 10128
Moshe Bressler, DO, 212-828-3120, moshe@optiskinmedical.com
Orit Markowitz, MD
About this study
Official title: Monitoring Response to Therapy in Atopic Dermatitis Patients Treated With Dupilumab Using Noninvasive Reflectance Confocal Microscopy and Optical Coherence Tomography
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)?"
Read the 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.
- Conditions
- Eczema, Atopic Dermatitis
- Being tested
- Dupilumab, Optical Coherence Tomography, Reflectance confocal microscopy
- Keywords
- dermatitis, Dupilumab, Inflammatory Skin Diseases, itch relief, biologic
- Medical subject headings
- Eczema, Dermatitis, Atopic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Dupixent
IL-4 antagonist to improve moderate-severe atopic dermatitis
Optical Coherence TomographyDevice
Also called OCT
OCT is a noninvasive imaging device that can be used to monitor inflammatory skin disorders.
Reflectance confocal microscopyDevice
Also called RCM
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.
| Study group | Role | What they receive |
|---|---|---|
| Dupixent | Experimental | Patients will receive initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week for 16 weeks.
Patients will self-administer by subcutaneous injection at home, instructions will be provided at first visit. Receives: Drug: Dupilumab; Device: Optical Coherence Tomography; Device: Reflectance confocal microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
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
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OptiSkin Medical
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Orit Markowitz MD, OptiSkin Medical
- Investigators
- Orit Markowitz, MD, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265234
- Sponsor's protocol ID
- OPTI-003
- Status last verified
- Feb 2022
- First submitted
- 16 Dec 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 25282559Simpson 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.
PubMed 27690741Meinke 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.
PubMed 25467783Byers 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.
PubMed 29675335Tang 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.
PubMed 24655575
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Response to Therapy in Atopic Dermatitis Patients Treated With Dupilumab Using Noninvasive Reflectance Confocal Microscopy and Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT05265234
- Acronym / sponsor ID
- OPTI-003
- Conditions
- Eczema, Atopic Dermatitis
- Keywords
- dermatitis, Dupilumab, Inflammatory Skin Diseases, itch relief, biologic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- OptiSkin MedicalUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Dupixent | Experimental | Drug: Dupilumab, Device: Optical Coherence Tomography, Device: Reflectance confocal microscopyPatients will receive initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week for 16 weeks. Patients will self-administer by subcutaneous injection at home, instructions will be provided at first visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: DupixentIL-4 antagonist to improve moderate-severe atopic dermatitis | Drug | Dupixent |
| Optical Coherence TomographyAlso: OCTOCT is a noninvasive imaging device that can be used to monitor inflammatory skin disorders. | Device | Dupixent |
| Reflectance confocal microscopyAlso: RCMRCM 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. | Device | Dupixent |
Primary outcome
Eczema Area and Severity Index (EASI)
Time frame: Baseline to 16 weeks
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.
Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD)
Time frame: Baseline to 16 weeks
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.
Noninvasive Imaging (clinical response) with Reflectance Confocal Microscopy (RCM)
Time frame: Baseline to 16 weeks
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.
Noninvasive Imaging (clinical response) with Optical Coherence Tomography (OCT)
Time frame: Baseline to 16 weeks
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Background: PubMed 25282559Leung 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.
- Background: PubMed 27690741Simpson 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.
- Background: PubMed 25467783Meinke 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.
- Background: PubMed 29675335Byers 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.
- Background: PubMed 24655575Tang 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.
- FDA Approved Drugs: DupixentLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Eczema
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orit Markowitz, MD principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dupilumab, Optical Coherence Tomography and Reflectance confocal microscopy in people with Eczema and Atopic Dermatitis, run by OptiSkin Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moshe Bressler, DO (212-828-3120, moshe@optiskinmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema Area and Severity Index (EASI) (time frame: Baseline to 16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05265234, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.