Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

Part of paid clinical trials in New York, New York.

Sponsor
OptiSkin Medical
Study ID
NCT05265234
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    IL-4 antagonist to improve moderate-severe atopic dermatitis
  • Optical Coherence Tomography — DEVICE
    OCT is a noninvasive imaging device that can be used to monitor inflammatory skin disorders.
  • Reflectance confocal microscopy — DEVICE
    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 Details

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)?"

Key Dates

Start date
Mar 1, 2022
Status verified
Feb 2022
Primary completion
Mar 1, 2023
Completion
Mar 1, 2024

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dupixent
    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.

Primary Outcome Measure

Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OptiSkin MedicalNew YorkNew York10128
Moshe Bressler, DO
[email protected]
212-828-3120
Orit Markowitz, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
OptiSkin Medical· New York, NY

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