Botulinum Toxin Blockade of Neuronal Signals to Immune Cells as a Novel Treatment for Hidradenitis Suppurativa
A legfontosabb adatok
- Hol
- Worcester (Egyesült Államok)A helyszín megnézése
- Fázis
- 2. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 13 és 75 év között vagy?
Forrás: NCT07756346: ki vehet részt
Helyszínek itt: Egyesült Államok
- UMass Chan Medical SchoolWorcester, Egyesült ÁllamokContact: Deborah WhiteNo longer taking part
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- University of Massachusetts, Worcester
- Azonosító
- NCT07756346
- A regiszteradat frissítve
- 2026. szeptember 10.
- Eredeti leírás
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..A teljes eredeti leírásKevesebb
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..
Bevonási feltételek: 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.
Kizáró feltételek: 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; 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,; 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; 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); pregnant or breastfeeding.