Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

NCT03103074 | Completed

• 1 other identifier: 2017/149 (REK)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Hidradenitis Suppurativa

Keywords

botulinum toxin

Outcome Measures

Primary Outcomes (1)

• Patient reported improvement after invention with Botulinum toxin B

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

  End point analysis 6 months

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Botulinum B Toxin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Botulinum B Toxin DRUG

Intradermal injections

Also known as: Neurobloc

Botulinum B Toxin

Placebo Saline OTHER

Intradermal injections

Also known as: Saline (NaCl 0,9%)

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University Hospital North Norway

Tromsø, 9038, Norway

Location

Related Publications (1)

• 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.

  PMID: 32761500 DERIVED

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

rimabotulinumtoxinB; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Øystein Grimstad, MD PhD

  Consultant NEHR-HUD/Postdoc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Partcipant and investigator/outcomes assessor are blinded. Treatment will be given after randomization by a secondary investigator.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md PhD

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

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: April 6, 2017
• Study Start: June 1, 2017
• Primary Completion: March 23, 2018
• Study Completion: September 23, 2018
• Last Updated: October 25, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)