Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

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

Full Title of Study: “Randomized Double Blind Placebo Controlled Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 23, 2018

Detailed Description

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.

Interventions

  • Drug: Botulinum B Toxin
    • Intradermal injections
  • Other: Placebo Saline
    • Intradermal injections

Arms, Groups and Cohorts

  • Experimental: Botulinum B Toxin
    • 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 Comparator: Placebo
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)
  • 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
  • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital of North Norway
  • Collaborator
    • The Royal Norwegian Ministry of Health
  • Provider of Information About this Clinical Study
    • Principal Investigator: Øystein Grimstad, Md PhD – University Hospital of North Norway
  • Overall Official(s)
    • Øystein Grimstad, MD PhD, Principal Investigator, Consultant NEHR-HUD/Postdoc

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