The Impact of Botox on Neuroimmune Interactions in Atopic Dermatitis (NCT06928246) | Clinical Trial Compass
RecruitingPhase 1
The Impact of Botox on Neuroimmune Interactions in Atopic Dermatitis
United States8 participantsStarted 2025-07-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Percentage change in EASI scores at Day 28 as compared to baseline.
Timeframe: At Day 28
2
Percentage change in PGA at Day 28 as compared to baseline.