Status:
RECRUITING
The Impact of Botox on Neuroimmune Interactions in Atopic Dermatitis
Lead Sponsor:
Daniel Kaplan
Collaborating Sponsors:
Almirall, S.A.
Conditions:
Atopic Dermatitis (AD)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
Atopic dermatitis is a debilitating chronic inflammatory disease with substantial health and economic impact, affecting 10-20% of the U.S. population with an estimated annual direct health care cost o...
Eligibility Criteria
Inclusion
- Phase 1b:
- Patients 18 years or older at time of consent
- Mild-to-Moderate AD, defined as:
- BSA ≤ 10%
- IGA ≤ 3
- No past biologic therapy
- No systemic therapy for 3 months
- No topical therapy for treatment of AD for 4 weeks
- Phase 2:
- Patients 18 years or older at time of consent
- Mild-to-Moderate AD, defined as:
- BSA ≤ 10%
- IGA ≤ 3
- At least one patch of eczema of at least 5 cm in diameter
- No past biologic therapy
- No systemic therapy for 3 months
- No topical therapy for treatment of AD for 4 weeks
Exclusion
- Phase 1b:
- Age less than 18 years old
- Pregnant or breastfeeding
- Has medical comorbidity such as end stage congestive heart failure or coagulopathy that is a relative contradiction to skin biopsy procedure
- Has had prior exposure to biologic treatments or has had prior treatment with systemic non-biologics (e.g. methotrexate) within 12 weeks
- Has used topical therapy for treatment of AD within 4 weeks
- Phase 2:
- Patients enrolled in Phase 1
- Age less than 18 years old
- Pregnant or breastfeeding
- Has medical comorbidity such as end stage congestive heart failure or coagulopathy that is a relative contradiction to skin biopsy procedure
- Has had prior exposure to biologic treatments or has had prior treatment with systemic non-biologics (e.g. methotrexate) within 12 weeks
- Has used topical therapy for treatment of AD within 4 weeks
Key Trial Info
Start Date :
July 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06928246
Start Date
July 17 2025
End Date
January 1 2026
Last Update
September 11 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
2
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, United States, 15213