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Pilot Study on Cellular and Molecular Impact of Neuroimmune Interactions in Atopic Dermatitis (AD)
The purpose of this study is to understand cellular and molecular interactions in the skin of participants with mild-to-moderate AD, and how botulinum toxin alters these interactions.
Details
| Lead sponsor | Daniel Kaplan |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 8 |
| Start date | 2025-07-17 |
| Completion | 2027-01 |
Conditions
- Atopic Dermatitis (AD)
Interventions
- Onabotulinum Toxin Type A - Phase 1b
- Onabotulinum Toxin Type A - Phase 2
Primary outcomes
- Percentage change in EASI scores at Day 28 as compared to baseline. — At Day 28
Eczema Area and Severity Index (EASI) total score from 0-72, with higher score indicating more severity. The EASI index assigns proportionate values to 4 body regions. Each region is assigned a score of 0 to 3, indicating none, mild, moderate, and severe clinical expression. The percentage of area involved is also assigned an eruption proportional score from 0 to 6. The total body score for each body region is obtained by multiplying the sum of the severity scores by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gives the EASI total from 0-72. - Percentage change in PGA at Day 28 as compared to baseline. — At Day 28
The Physician's Global Assessment (PGA) is a clinician-reported measure used to assess the overall severity of atopic dermatitis (AD) at a single time point. It utilizes a scale of 5-points; total scale ranging from 0 (clear) to 5 (severe disease). The PGA score represents overall disease severity based on clinical signs including erythema, induration/papulation, lichenification, and oozing/crusting. Higher scores indicate greater disease severity.
Countries
United States