Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

University Hospital of North Norway20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hidradenitis Suppurativa

Interventions

Botulinum B ToxinDRUG

Intradermal injections

Placebo SalineOTHER

Intradermal injections

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital North Norway

Tromsø, Norway

Outcomes

Primary Outcomes

Patient reported improvement after invention with Botulinum toxin B

Outcome measured by Dermatological Life Quality Index (DLQI)-scores

Time frame: End point analysis 6 months

Secondary Outcomes

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)

Time frame: 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

Time frame: 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)

Time frame: Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months

Data from ClinicalTrials.gov

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