Recruiting

Dupilumab

Sponsor:

OptiSkin Medical

Code:

NCT05265234

Conditions

Eczema

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dupilumab

Optical Coherence Tomography

Reflectance confocal microscopy

Study Details

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)?"

Conditions

Eczema

Atopic Dermatitis

Study ID

NCT05265234

Start date

Mar 1, 2022

Status verified date

Feb, 2022

Completion date

Mar 1, 2024

Anticipated

Primary completion date

Mar 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Dupilumab

IL-4 antagonist to improve moderate-severe atopic dermatitis

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.

Primary outcome measure

  • Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to 16 weeks ]
  • Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) [ Time Frame: Baseline to 16 weeks ]
  • Noninvasive Imaging (clinical response) with Reflectance Confocal Microscopy (RCM) [ Time Frame: Baseline to 16 weeks ]
  • Noninvasive Imaging (clinical response) with Optical Coherence Tomography (OCT) [ Time Frame: Baseline to 16 weeks ]

Central Contacts and Locations

Central contacts

Moshe Bressler, DO

212-828-3120moshe@optiskinmedical.com

Orit Markowitz, MD

212-828-3120clinicaltrials@optiskinmedical.com

Locations

OptiSkin Medical

Recruiting

New York, New York, United States, 10128

Contacts

Moshe Bressler, DO

212-828-3120moshe@optiskinmedical.com

Principal Investigator:

Orit Markowitz, MD

More Information

Sponsor

OptiSkin Medical

Last update posted

Mar 3, 2022

Last verified

Feb, 2022

Keywords

  • dermatitis
  • Dupilumab
  • Inflammatory Skin Diseases
  • itch relief
  • biologic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OptiSkin Medical on 2022-03-03.