Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

October 24, 2018 updated by: Øystein Grimstad, University Hospital of North Norway

Randomized Double Blind Placebo Controlled 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tromso, Norway, 9038
        • University Hospital North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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)
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
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
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
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)
Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

March 23, 2018

Study Completion (ACTUAL)

September 23, 2018

Study Registration Dates

First Submitted

March 17, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (ACTUAL)

April 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/149 (REK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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