The Impact of Botox on Neuroimmune Interactions in Atopic Dermatitis

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Daniel Kaplan
Study ID
NCT06928246
Phase
PHASE1
Status
Recruiting
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Conditions

  • Atopic Dermatitis (AD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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 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.

Study Details

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.

Key Dates

Start date
Jul 17, 2025
Status verified
May 2026
Primary completion
Dec 15, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Onabotulinum Toxin Type A - Phase 1b
    Onabotulinum toxin administered to two lesions.
  • Experimental: Onabotulinum Toxin Type A - Phase 2
    Onabotulinum toxin administered to three lesions.

Primary Outcome Measure

Percentage change in EASI scores at Day 28 as compared to baseline. [ Time Frame: At Day 28 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Anna Davis, MD
[email protected]
4126475633
Charity Ruhl, LPN
[email protected]
4126472013
Daniel H Kaplan, MD, PhD (PRINCIPAL_INVESTIGATOR)
Joe K Tung, MD, MBA (SUB_INVESTIGATOR)
UPMC Department of DermatologyPittsburghPennsylvania15213
Neethi Francis, MA
[email protected]
4126474023
Charity Ruhl, LPN
[email protected]
4126475633
Joe Tung, MD, MBA (SUB_INVESTIGATOR)

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By research site
University of Pittsburgh Medical Center· Pittsburgh, PAUPMC Department of Dermatology· Pittsburgh, PA

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