Recruiting

Botulinum Toxin

Sponsor:

University of Massachusetts, Worcester

Code:

NCT05403710

Conditions

Hidradenitis Suppurativa

Hyperhidrosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Botulinum toxin

Study Details

Brief summary:

This study will build on data from mice and humans implicating TRPV1 nociceptors in the pathogenesis of the type-17 chronic inflammatory skin disease Hidradenitis Suppurativa (HS). In this study, the investigators will test the hypothesis that inhibiting neuropeptide activity with botulinum toxin reduces pathogenic inflammation.

Conditions

Hidradenitis Suppurativa

Hyperhidrosis

Study ID

NCT05403710

Start date

Jun 7, 2022

Status verified date

Aug, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion:

  • Adults between ages 18 and 75 years with established diagnosis of hidradenitis suppurativa (HS)
  • HS skin lesions of duration at least 1 year, HS skin lesions in at least two different body areas

Exclusion:

  • Age < 18 years or > 75 years
  • pregnant or breastfeeding
  • neuromuscular disorder (ex. ALS, myasthenia gravis, Lambert-Eaton syndrome, myopathy)
  • medical co-morbidity that is a relative contraindication to skin biopsy procedure (ex. end stage congestive heart failure or coagulopathy)
  • active bacterial, fungal, or viral infection in the treatment area
  • known hypersensitivity to botulinum toxin A preparations or any of their components (human albumin, saline, lactose, sodium succinate)
  • prisoners
  • adults unable to consent for themselves.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

single group assignment

men or women between the ages of 18-75 who have an established diagnosis of Hidradenitis Suppurativa

Interventions

Botulinum toxin

Administration of botulinum toxin (50 units/100cm2 injected intradermally) into lesional skin

Primary outcome measure

  • Quantification and phenotyping of skin resident dendritic cell, macrophage, and T cell populations in patients before and after intralesional Botox treatment. [ Time Frame: 1-2 months after first treatment ]

Central Contacts and Locations

Central contacts

Sarah K Whitley, MD PhD

(508)856-4086sarah.whitley@umassmed.edu

Deborah White, Deborah Peduzzi

(508)856-2664deborah.white@umassmed.edu

Locations

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

Sidney Leno, MD

774-455-4087hsresearch@umassmed.edu

Terrie Lamarche

508-856-5386terrie.lamarche@umassmed.edu

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-08-07.