Hidradenitis Suppurativa (HS)Phase 2Botox in HSNCT07756346
Botulinum Toxin Blockade of Neuronal Signals to Immune Cells as a Novel Treatment for Hidradenitis Suppurativa
A Phase 2 study testing Botulinum Toxin A (Allergan, Inc, Irvine CA) in people with Hidradenitis Suppurativa (HS), run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 75 years
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- Botulinum Toxin A (Allergan, Inc, Irvine CA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Apr 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >13 and <75
- established diagnosis of HS
- HS skin lesions of duration at least 1 year
- HS lesions in at least two distinct body areas
- inadequate response to a trial of an oral antibiotic or exhibited recurrence after discontinuation of antibiotics
- abscess and nodule (AN) count ≥ 5 at baseline
- draining tunnel count of <20 at baseline
- ability to provide written informed consent and/or assent
Who cannot join
- pregnant or breastfeeding
- history of neuromuscular disorder (ex. ALS, myasthenia gravis, Lambert-Eaton syndrome, myopathy
- medical co-morbidity ex. end stage congestive heart failure or coagulopathy that is a relative contradiction to skin biopsy procedure
- received systemic steroids or started a new systemic (biologic or non-biologic immunomodulator, oral retinoid) therapy with potential therapeutic impact for HS <12 weeks prior to baseline visit
- use of opioid or non-opioid oral analgesics within 14 days of baseline visit (exception: at a stable dose for at least 14 days prior to baseline)
- receiving anti-IL-17A/F, anti-IL-23, or anti-IL-1 biologic therapy or oral JAK inhibitor, TYK inhibitor
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- active COVID-19 infection or history of COVID-19 infection within 4 weeks prior to baseline
- oral or IV antibiotic use during the treatment period (exception: stable dose of doxycycline or minocycline upto 100mg PO BID for 28 days prior to baseline and throughout the 6 month treatment and observation period
- initiation of topical therapies for HS within 14 days or baseline visit (may continue stable use of topical therapies started > 14 days prior to baseline visit), -laser surgery, laser hair removal, or elective surgery to treatment areas within 4 weeks prior to baseline visit
- current participation in another clinical study involving the administration of an investigative drug for the treatment of HS, or prior participation in such a study within 60 days prior to baseline visit,
- active bacterial, fungal, or viral infection in the treatment area at baseline visit, -immunocompromised state
- known hypersensitivity to botulinum toxin A preparations or any of their components (human albumin, saline, lactose, sodium succinate).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Terrie LaMarche contact
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01605
Deborah White, (508)856-2664, deborah.white@umassmed.edu
Sidney Leno, MD, 714-455-4087, sidney.leno@umassmed.edu
About this study
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 extend data from a 12-week pilot study to rigorously test the hypothesis that botulinum toxin (BoNT) therapy reduces disease severity and relieves HS pain symptoms..
Read the detailed description
This study will recruit 40 HS patients with an abscess and inflammatory nodule (AN) count ≥5 at a single body site (ex. bilateral axillae, medial thighs). Participants will be randomized 1:1 to receive placebo or 50U of BoNT per 100cm2 of skin (100U total) administered twice over a 6-month study period. Randomization will be stratified by disease stage (Hurley stage <III, III). At baseline and weeks 4, 12, and 24 disease activity and pain symptom burden will be measured using percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count as primary outcomes and achievement of ≥ 30% reduction from baseline in the Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS)-30 as a secondary outcome. The investigators will conduct high-frequency ultrasound measurement of HS tunnel area at baseline and weeks 4,12, and 24 to determine if BoNT therapy can reduce tunnel size. The study team will also collect punch biopsies of lesional skin from HS patients before, and 4 weeks after BoNT treatment then perform flow cytometric, transcriptomic, and microscopic analysis of skin to determine if and how nonselective inhibition of neuropeptide release diminishes HS inflammation.
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- Botulinum Toxin A (Allergan, Inc, Irvine CA), Placebo
- Keywords
- botulinum toxin, Botox, ultrasound, tunnel area, mechanistic
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin A (Allergan, Inc, Irvine CA)Drug
50U per axilla in 10 injections of 0.1mL
PlaceboDrug
Also called saline
10 injections of 0.1mL of normal saline vehicle per laterality
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Participants will be randomized 1:1 to receive placebo (saline) or botulinum toxin injections. Receives: Drug: Placebo |
| botulinum toxin | Active comparator | Participants will be randomized 1:1 to receive placebo (saline) or botulinum toxin injections. Receives: Drug: Botulinum Toxin A (Allergan, Inc, Irvine CA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count
All subjects will receive 2 treatments with onabotulinum toxin A OR placebo (saline) 3 months apart, over a 6-month study period. At baseline and at week 12 each patient will receive 50 units of Botox per 100cm2 of skin, injected intradermally in 10 injections of 0.1mL spaced 1 cm apart to one HS-affected body site (ex. bilateral axillae, inguinal, medial thighs, inframammary chest) for a total of 100U per treatment.
Measured: baseline and weeks 4, 12, and 24
Microscopy Analyses of Skin Lesions
The study team will perform punch biopsies of lesions and non-lesional skin and perform direct immunohistochemistry and immunofluoresce microscopy analysis
Measured: baseline and day 7
Ultrasound monitoring of skin lesions
Ultra-high frequency ultrasound (UHFU): This non- invasive imaging technique will be used to quantify HS tunnel area and cutaneous blood flow rate in treatment areas using an established protocol as detailed in Oranges T Skin Res Technology 2020).
Measured: baseline and weeks 1, 12, 24
Secondary outcomes (13)
Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)
Response is defined as at least a 2-point reduction in HS-IGA score relative to baseline.
Measured: baseline and weeks 1, 12 ,24
Central sensitization Index (CSI)
measures centrally processed pain signals. The participant scores each answer on a scale of 0 (never) to 4 (always). A score of more than 40 indicates the presence of central sensitization.
Measured: baseline and weeks 1, 12, 24
Numeric Rating Scale -30
The numeric rating scale (NRS) is a pain scale that asks a patient to rate their pain on a scale of 0 to 10 where a higher score indicates a higher pain level. It's a common tool used in healthcare to assess pain severity.
Measured: baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Clinical Response (HiSCR)-50
defined as a 50% reduction in inflammatory lesion count (abscesses + inflammatory nodules) with no increase in abscesses or draining fistulas when compared with baseline.
Measured: baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Physician Global Assessment (HS-PGA)
The six-point Hidradenitis Suppurativa Physician Global Assessment (PGA) ranges from clear to very severe where a higher score indicates more severe disease. It is used in clinical trials to measure clinical improvement in inflammatory nodules,abscesses and draining fistulae
Measured: baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Quality of Life (HiSQOL)
A 17-item questionnaire designed to measure quality of life for people with HS. Scores range from 0-68 where higher scores indicate a worse impact on quality of life.
Measured: baseline and weeks 1, 12, 24
Dermatology Quality of Life Index
Assesses the degree of pain, the number of flares, and the impact on daily life . Dermatology disease agnostic, not specific for HS
Measured: baseline and weeks 1, 12, 24
International Hidradenitis Suppurativa Severity Score (IHS-4)
The International Hidradenitis Suppurativa Severity Score (IHS4) is a validated tool that measures the severity of hidradenitis suppurativa (HS). The IHS4 score is calculated by adding the number of nodules, abscesses, and draining tunnels, each multiplied by a weight A score of 3 or less indicates mild HS, 4-10 indicates moderate HS, and 11 or higher indicates severe HS. The IHS4 is used to assess the severity of HS and to measure inflammatory lesions, such as draining tunnels.
Measured: baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Area and Severity Index Revised
The HASI-R method assesses HS severity in a manner that incorporates signs of inflammation and body surface area involved. Scores range from 0-720 where a higher score indicates worse disease.
Measured: baseline and weeks 1, 12, 24
Numeric Rating Scale - Itch
rates itch score as 1-10, 10 indicating most severe itch. similar to NRS pain instrument
Measured: baseline and weeks 1, 12, 24
PainDETECT
an assessment tool for neuropathic pain. Scores range from -1 to 38. A score of 19 or higher indicates neuropathic pain is likely.
Measured: baseline and weeks 1, 12, 24
Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 (General Anxiety Disorder-7) measures severity of anxiety over a 2 week period. Answers are scored from 0 to 3 ("not at all" = 0, "several days" = 1, "more than half the days" = 2, and "nearly every day"=3). A score of 10 or higher is considered positive for anxiety.
Measured: baseline
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 (Patient Health Questionnaire-9) objectifies and assesses degree of depression severity via questionnaire. Nine questions indicate how often the symptom occurred over a 2-week period. A score of 10 or higher is considered clinically significant.
Measured: baseline and weeks 1, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, phase 2, randomized, placebo-controlled clinical trial of botulinum toxin (BoNT) in patients with moderate to severe hidradenitis suppurativa (HS).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Sarah Whitley, University of Massachusetts, Worcester
- Investigators
- Sarah K Whitley, MD, PhD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756346
- Sponsor's protocol ID
- STUDY00003339
- Other IDs
- 1R61AR087105-01A1
- Acronym
- Botox in HS
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research team will share data and samples from this study with other investigators who are interested in skin diseases, but in that case no patient identifying information will be shared.
Publications
Kim YS, Hong ES, Kim HS. Botulinum Toxin in the Field of Dermatology: Novel Indications. Toxins (Basel). 2017 Dec 16;9(12):403. doi: 10.3390/toxins9120403.
PubMed 29258169Kimball AB, Sobell JM, Zouboulis CC, Gu Y, Williams DA, Sundaram M, Teixeira HD, Jemec GB. HiSCR (Hidradenitis Suppurativa Clinical Response): a novel clinical endpoint to evaluate therapeutic outcomes in patients with hidradenitis suppurativa from the placebo-controlled portion of a phase 2 adalimumab study. J Eur Acad Dermatol Venereol. 2016 Jun;30(6):989-94. doi: 10.1111/jdv.13216. Epub 2015 Jul 22.
PubMed 26201313Campanati A, Martina E, Giuliodori K, Consales V, Bobyr I, Offidani A. Botulinum Toxin Off-Label Use in Dermatology: A Review. Skin Appendage Disord. 2017 Mar;3(1):39-56. doi: 10.1159/000452341. Epub 2017 Feb 1.
PubMed 28612001Grimstad O, Kvammen BO, Swartling C. Botulinum Toxin Type B for Hidradenitis Suppurativa: A Randomised, Double-Blind, Placebo-Controlled Pilot Study. Am J Clin Dermatol. 2020 Oct;21(5):741-748. doi: 10.1007/s40257-020-00537-9.
PubMed 32761500Shih T, Lee K, Seivright JR, De DR, Shi VY, Hsiao JL. Hyperhidrosis treatments in hidradenitis suppurativa: A systematic review. Dermatol Ther. 2022 Jan;35(1):e15210. doi: 10.1111/dth.15210. Epub 2021 Nov 30.
PubMed 34796606Campanati A, Martina E, Giuliodori K, Bobyr I, Consales V, Offidani A. Two cases of Hidradenitis suppurativa and botulinum toxin type a therapy: A novel approach for a pathology that is still difficult to manage. Dermatol Ther. 2019 May;32(3):e12841. doi: 10.1111/dth.12841. Epub 2019 Feb 10.
PubMed 30693648