The Impact of Botox on Neuroimmune Interactions in Atopic Dermatitis
Recruiting · NCT06928246 · Interventional (participants receive a specific treatment) · Lead sponsor: Daniel Kaplan
View the official record on ClinicalTrials.gov →Interventions studied
Onabotulinum Toxin Type A - Phase 1bOnabotulinum Toxin Type A - Phase 2
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
2 locations listed across 1 US state.
- University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania, United States
- UPMC Department of Dermatology - Pittsburgh, Pennsylvania, United States