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| Name | Class |
|---|---|
| The Royal Norwegian Ministry of Health | OTHER |
| Hidrosis Clinic, Stockholm, Sweden | OTHER |
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Randomized double blind placebo controlled pilot study/proof of concept-study to see if intradermal injection with Botulinum toxin B is an effective treatment of Hidradenitis suppurativa
Twenty patients with hidradenitis suppurativa will be enrolled and randomised to treatment with either botulinum toxin B or placebo (saline) in affected areas.
Intervention and recording of data will be performed every three months. After three months, all patients will receive active substance. After six months, randomization will revealed. Patients with clinical improvement will be given the opportunity to continue treatment for additional six months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum B Toxin | Experimental | Botulinum toxin B (Neurobloc(R)) 50 Units (U)/ml 0,05-0,1 ml/injection intradermally in a grid with 1- 1 1/2 cm between every injection in affected areas A maximum of 4000 U/patient/treatment Treatment every three months |
|
| Placebo | Placebo Comparator | Saline (NaCl 0,9%) 0,05-0,1 ml/injection intradermally in a grid With 1- 1 1/2 cm between every injection in affected areas Treatment in placebo group (n=10) only at first intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum B Toxin | Drug | Intradermal injections |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported improvement after invention with Botulinum toxin B | Outcome measured by Dermatological Life Quality Index (DLQI)-scores | End point analysis 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of clinical subgroups with best response to intervention as assessed by clinically scored measures | Registration and analysis on investigator scored measures assessed by Hidradenitis suppurativa score (HiSCR) in relation to clinical phenotypes (location, Hurley stage) | Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating, as well as patients with neurological disease such as myasthenia gravis or motor neuron disease.
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| Name | Affiliation | Role |
|---|---|---|
| Øystein Grimstad, MD PhD | Consultant NEHR-HUD/Postdoc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital North Norway | Tromsø | 9038 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32761500 | Derived | Grimstad 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. |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C096323 | rimabotulinumtoxinB |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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First treatment - one placebo and one active substance group Thereafter - all patients receive active substance
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Partcipant and investigator/outcomes assessor are blinded. Treatment will be given after randomization by a secondary investigator.
| Placebo Saline | Other | Intradermal injections |
|
|
| Identify if covariates such as age, disease duration, smoking state, BMI and sweating influence patient reported improvement | Covariate analysis on patient recorded DLQI in relation to pre-registered variables | Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months |
| Identification of clinical subgroups with best response to intervention as assessed by patient reported improvement | Registration and analysis on patient recorded DLQI in relation to clinical phenotypes (location, Hurley stage) | Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
| D017670 |
| Sodium Compounds |