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NCT Number: NCT03103074

Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

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

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital North Norway

Tromsø, 9038, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum B Toxin

Drug

Intradermal injections

Other names: Neurobloc

Placebo saline

Other

Intradermal injections

Other names: Saline (NaCl 0,9%)

Primary outcomes

  1. Patient reported improvement after invention with Botulinum toxin B

    Time frame: End point analysis 6 months

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

Secondary outcomes

  1. Identification of clinical subgroups with best response to intervention as assessed by clinically scored measures

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

    Registration and analysis on investigator scored measures assessed by Hidradenitis suppurativa score (HiSCR) in relation to clinical phenotypes (location, Hurley stage)

  2. Identify if covariates such as age, disease duration, smoking state, BMI and sweating influence patient reported improvement

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

    Covariate analysis on patient recorded DLQI in relation to pre-registered variables

  3. Identification of clinical subgroups with best response to intervention as assessed by patient reported improvement

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

    Registration and analysis on patient recorded DLQI in relation to clinical phenotypes (location, Hurley stage)

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Hidrosis Clinic, Stockholm, Sweden
  • The Royal Norwegian Ministry of Health

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2017
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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