Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Randomized Double Blind Placebo Controlled Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Botulinum B Toxin
* Other: Placebo Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with active hidradenitis in the stage I-III according to Hurleys classification. Patients are referred to a dermatology out-patient clinic or patients already in an established treatment program, where there is indication for new or different treatment, or surgical intervention. Patients must have typical affection of the disease of either axillae, groins, and/or perigenital/perianal area Exclusion Criteria: Patients in need of emergency medical or surgical treatment of hidradenitis will be excluded until the disease is in a quiet, controlled phase. Pregnant or lactating, as well as patients with neurological disease such as myasthenia gravis or motor neuron disease.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: First treatment - one placebo and one active substance group Thereafter - all patients receive active substance
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum B Toxin<br>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 | Drug: Botulinum B Toxin<br>* Intradermal injections<br>* Other names: Neurobloc;|
| Placebo Comparator: Placebo<br>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 | Other: Placebo Saline<br>* Intradermal injections<br>* Other names: Saline (NaCl 0,9%);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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botulinum toxin