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Search / Trial NCT06928246

The Impact of Botox on Neuroimmune Interactions in Atopic Dermatitis

Launched by DANIEL KAPLAN · Apr 7, 2025

Trial Information

Current as of September 10, 2025

Not yet recruiting

Keywords

Atopic Dermatitis Eczema Botox

ClinConnect Summary

The clinical trial titled "The Impact of Botox on Neuroimmune Interactions in Atopic Dermatitis" is designed to explore how Botox, a treatment commonly known for reducing wrinkles, affects the skin and immune interactions in people with mild to moderate atopic dermatitis (AD), a chronic skin condition that causes itchy and inflamed patches. The study aims to understand these interactions better, which could lead to new treatment options for those suffering from this condition.

To be eligible for the trial, participants must be 18 years or older and have mild to moderate AD, which means their skin condition covers no more than 10% of their body and is rated as mild to moderate on a specific scale. They also should not have used certain treatments, like systemic medications or biologic therapies, for a specific period before joining the study. While the trial is not recruiting participants yet, those who qualify will have the chance to contribute to important research that could help improve the understanding and management of atopic dermatitis. Participants can expect to undergo skin assessments and possibly receive Botox treatment as part of the study.

Gender

ALL

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

About Daniel Kaplan

Daniel Kaplan is a dedicated clinical trial sponsor with a robust commitment to advancing medical research and innovation. With a focus on developing cutting-edge therapies and improving patient outcomes, the organization collaborates with leading researchers and institutions to conduct rigorous clinical studies across various therapeutic areas. Daniel Kaplan prioritizes ethical standards and regulatory compliance, ensuring the highest quality in trial design and execution. Through its strategic partnerships and emphasis on patient-centric approaches, the organization aims to contribute significantly to the evolving landscape of healthcare and the development of transformative treatments.

Locations

Pittsburgh, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Daniel Kaplan, MD, PhD

Principal Investigator

University of Pittsburgh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported