The Impact of Botox on Neuroimmune Interactions in Atopic Dermatitis
Pilot Study on Cellular and Molecular Impact of Neuroimmune Interactions in Atopic Dermatitis
Daniel Kaplan
8 participants
Jul 17, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria17
- 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 Criteria13
- 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
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Interventions
The lesions receiving Botulinum toxin will get five 0.1 mL intradermal injections of 5 units of Botulinum toxin which equates to 25 units per lesion and 50 units per patient.
The lesions receiving Botulinum toxin will get five 0.1 mL intradermal injections of 5 units of Botulinum toxin which equates to 25 units per lesion and 75 units per patient.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06928246