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Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

Primary Purpose

Hidradenitis Suppurativa

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Botulinum B Toxin

Placebo Saline

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring botulinum toxin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospital North Norway

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botulinum B Toxin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Patient reported improvement after invention with Botulinum toxin B

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

Secondary Outcome Measures

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)

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

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)

Full Information

NCT ID

NCT03103074

First Posted

March 17, 2017

Last Updated

October 24, 2018

Sponsor

University Hospital of North Norway

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03103074

Brief Title

Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

March 23, 2018 (Actual)

Study Completion Date

September 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital of North Norway

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hidradenitis Suppurativa

Keywords

botulinum toxin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

First treatment - one placebo and one active substance group Thereafter - all patients receive active substance

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Partcipant and investigator/outcomes assessor are blinded. Treatment will be given after randomization by a secondary investigator.

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Botulinum B Toxin

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Botulinum B Toxin

Other Intervention Name(s)

Neurobloc

Intervention Description

Intradermal injections

Intervention Type

Other

Intervention Name(s)

Placebo Saline

Other Intervention Name(s)

Saline (NaCl 0,9%)

Intervention Description

Intradermal injections

Primary Outcome Measure Information:

Title

Patient reported improvement after invention with Botulinum toxin B

Description

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

Time Frame

End point analysis 6 months

Secondary Outcome Measure Information:

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Øystein Grimstad, MD PhD

Organizational Affiliation

Consultant NEHR-HUD/Postdoc

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital North Norway

City

Tromso

ZIP/Postal Code

9038

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32761500

Citation

Grimstad O, Kvammen BO, Swartling C. Botulinum Toxin Type B for Hidradenitis Suppurativa: A Randomised, Double-Blind, Placebo-Controlled Pilot Study. Am J Clin Dermatol. 2020 Oct;21(5):741-748. doi: 10.1007/s40257-020-00537-9.

Results Reference

derived

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Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

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