The Impact of Botox on Neuroimmune Interactions in Atopic Dermatitis

NCT06928246 | Recruiting Phase 1 FDA Drug

• 1 other identifier: STUDY24110067
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Atopic Dermatitis (AD)

Keywords

Atopic dermatitis; Eczema; Botox

Outcome Measures

Primary Outcomes (2)

• Percentage change in EASI scores at Day 28 as compared to baseline.

  Eczema Area and Severity Index (EASI) total score from 0-72, with higher score indicating more severity. The EASI index assigns proportionate values to 4 body regions. Each region is assigned a score of 0 to 3, indicating none, mild, moderate, and severe clinical expression. The percentage of area involved is also assigned an eruption proportional score from 0 to 6. The total body score for each body region is obtained by multiplying the sum of the severity scores by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gives the EASI total from 0-72.

  At Day 28

• Percentage change in PGA at Day 28 as compared to baseline.

  The Physician's Global Assessment (PGA) is a clinician-reported measure used to assess the overall severity of atopic dermatitis (AD) at a single time point. It utilizes a scale of 5-points; total scale ranging from 0 (clear) to 5 (severe disease). The PGA score represents overall disease severity based on clinical signs including erythema, induration/papulation, lichenification, and oozing/crusting. Higher scores indicate greater disease severity.

  At Day 28

Secondary Outcomes (2)

• Percentage change in transcriptional mRNA in immune and non-immune cells in skin biopsies, up to Day 28, as compared to baseline.

  Until last biopsy, up to Day 28

• Percentage change in spatial distribution of specific cell types in skin biopsies, up to Day 28, as compared to baseline.

  Until last biopsy, up until Day 28

Study Arms (2)

Onabotulinum Toxin Type A - Phase 1b

EXPERIMENTAL

Onabotulinum toxin administered to two lesions.

Drug: Onabotulinum Toxin Type A - Phase 1b

Onabotulinum Toxin Type A - Phase 2

EXPERIMENTAL

Onabotulinum toxin administered to three lesions.

Drug: Onabotulinum Toxin Type A - Phase 2

Interventions

Onabotulinum Toxin Type A - Phase 1b DRUG

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.

Onabotulinum Toxin Type A - Phase 1b

Onabotulinum Toxin Type A - Phase 2 DRUG

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.

Onabotulinum Toxin Type A - Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniel Kaplan: lead
• Almirall, S.A.: collaborator

Study Sites (2)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (2)

• Popescu MN, Beiu C, Iliescu MG, Mihai MM, Popa LG, Stanescu AMA, Berteanu M. Botulinum Toxin Use for Modulating Neuroimmune Cutaneous Activity in Psoriasis. Medicina (Kaunas). 2022 Jun 16;58(6):813. doi: 10.3390/medicina58060813.

  PMID: 35744076 BACKGROUND

• Khattab FM. Evaluation of Botulinum Toxin A as an Optional Treatment for Atopic Dermatitis. J Clin Aesthet Dermatol. 2020 Jul;13(7):32-35. Epub 2020 Jul 1.

  PMID: 32983334 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Daniel Kaplan, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charity Ruhl, LPN

CONTACT

4126472013; ruhlcl@upmc.edu

Anna Davis, MD

CONTACT

4126475633; davisa60@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: From end of study up to two years.
• Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.

Locations

US (2)