Pilot Study on Cellular and Molecular Impact of Neuroimmune Interactions in Atopic Dermatitis
Daniel Kaplan
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.
Description
Atopic dermatitis is a debilitating chronic inflammatory disease with substantial health and economic impact, affecting 10-20% of the U.S. population with an estimated annual direct health care cost of $13 billion. There is much to still discover regarding the dysfunctional skin barrier underlying AD and its effects on quality of life, highlighting a critical health care cap. AD manifests as erythematous and pruritic plaques often in flexural regions of the body, but may also be widespread as well. AD patients suffer from high rates of mental health disorders and often report a poor quality of…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugOnabotulinum Toxin Type A - Phase 1b
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.
- DrugOnabotulinum Toxin Type A - Phase 2
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)
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- UPMC Department of DermatologyPittsburgh, Pennsylvania