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Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

Sponsor
University Hospital of North Norway (Other)
Overall Status
Completed
CT.gov ID
NCT03103074
Collaborator
The Royal Norwegian Ministry of Health (Other), Hidrosis Clinic, Stockholm, Sweden (Other)
20
Enrollment
1
Location
2
Arms
15.7
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Botulinum B Toxin
  • Other: Placebo Saline
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
First treatment - one placebo and one active substance group Thereafter - all patients receive active substanceFirst treatment - one placebo and one active substance group Thereafter - all patients receive active substance
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Partcipant and investigator/outcomes assessor are blinded. Treatment will be given after randomization by a secondary investigator.
Primary Purpose:
Treatment
Official Title:
Randomized Double Blind Placebo Controlled Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa
Actual Study Start Date :
Jun 1, 2017
Actual Primary Completion Date :
Mar 23, 2018
Actual Study Completion Date :
Sep 23, 2018

Arms and Interventions

Arm Intervention/Treatment
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

Drug: Botulinum B Toxin
Intradermal injections
Other Names:
  • Neurobloc

    		•
    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

    Other: Placebo Saline
    Intradermal injections
    Other Names:
  • Saline (NaCl 0,9%)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Patient reported improvement after invention with Botulinum toxin B [End point analysis 6 months]

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

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital North Norway Tromso Norway 9038

    Sponsors and Collaborators

    • University Hospital of North Norway
    • The Royal Norwegian Ministry of Health
    • Hidrosis Clinic, Stockholm, Sweden

    Investigators

    • Principal Investigator: Øystein Grimstad, MD PhD, Consultant NEHR-HUD/Postdoc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Øystein Grimstad, Md PhD, University Hospital of North Norway
    ClinicalTrials.gov Identifier:
    NCT03103074
    Other Study ID Numbers:
    • 2017/149 (REK)
    First Posted:
    Apr 6, 2017
    Last Update Posted:
    Oct 25, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Øystein Grimstad, Md PhD, University Hospital of North Norway
    botulinum toxin
    Additional relevant MeSH terms:
    Hidradenitis Suppurativa
    Hidradenitis
    rimabotulinumtoxinB

    Study Results

    No Results Posted as of Oct 25, 2018