NCT06928246 The Impact of Botox on Neuroimmune Interactions in Atopic Dermatitis
| NCT ID | NCT06928246 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Daniel Kaplan |
| Condition | Atopic Dermatitis (AD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2025-07-17 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 8 participants in total. It began in 2025-07-17 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Daniel Kaplan, MD, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06928246 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atopic Dermatitis (AD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06928246 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06928246 currently recruiting?
Yes, NCT06928246 is actively recruiting participants. Contact the research team at ruhlcl@upmc.edu for enrollment information.
Where is the NCT06928246 trial being conducted?
This trial is being conducted at Pittsburgh, United States, Pittsburgh, United States.
Who is sponsoring the NCT06928246 clinical trial?
NCT06928246 is sponsored by Daniel Kaplan. The principal investigator is Daniel Kaplan, MD, PhD at University of Pittsburgh. The trial plans to enroll 8 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.