Trials / Unknown
UnknownNCT05265234
Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.
Monitoring Response to Therapy in Atopic Dermatitis Patients Treated With Dupilumab Using Noninvasive Reflectance Confocal Microscopy and Optical Coherence Tomography
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- OptiSkin Medical · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DEVICE | 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. |
Timeline
- Start date
- 2022-03-01
- Primary completion
- 2023-03-01
- Completion
- 2024-03-01
- First posted
- 2022-03-03
- Last updated
- 2022-03-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05265234. Inclusion in this directory is not an endorsement.