Botox's effect on skin nerve and immune interactions in atopic dermatitis
Pilot Study on Cellular and Molecular Impact of Neuroimmune Interactions in Atopic Dermatitis
We will test whether Botox injections change how nerves and immune cells interact in adults with mild-to-moderate atopic dermatitis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 2 sites (Pittsburgh, Pennsylvania and 1 other locations) |
| Trial ID | NCT06928246 on ClinicalTrials.gov |
What this trial studies
This Phase 1 pilot gives onabotulinum toxin A injections into affected skin and uses serial skin biopsies to measure cellular and molecular changes in adults with mild-to-moderate atopic dermatitis. Investigators will compare lesional and non-lesional skin before and after treatment to see whether cutaneous neurons help maintain AD lesions through neuro-immune signaling. Participants must meet washout requirements for systemic and topical therapies and may not have prior biologic treatment. Primary endpoints include changes in neuro-immune signaling markers and the local safety and tolerability of cutaneous botulinum toxin application.
Who should consider this trial
Good fit: Adults 18 and older with mild-to-moderate AD (BSA ≤10%, IGA ≤3), no recent systemic or topical AD therapies, and no prior biologic treatment are the intended participants.
Not a fit: Patients with severe AD, recent biologic or systemic therapy, pregnant or breastfeeding individuals, or those with medical conditions that preclude skin biopsy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the work could reveal nerve-related targets and lead to new treatments that reduce itching and inflammation in atopic dermatitis.
How similar studies have performed: Small studies of botulinum toxin have shown benefit for itch or hyperhidrosis, but using Botox to probe neuro-immune mechanisms in AD is largely novel and untested in larger trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania and 1 other locations
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
- UPMC Department of Dermatology — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Kaplan, MD, PhD — University of Pittsburgh
- Study coordinator: Charity Ruhl, LPN
- Email: ruhlcl@upmc.edu
- Phone: 4126472013
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.