Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

Not Applicable

Completed

• Conditions: Hidradenitis Suppurativa
• Interventions: Other: Placebo Saline; Drug: Botulinum B Toxin

• Registration Number: NCT03103074
• Lead Sponsor: University Hospital of North Norway

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.

Study Timeline

• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-06
• Study Start: 2017-06-01
• Primary Completion: 2018-03-23
• Study Completion: 2018-09-23
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-24
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Saline	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
Botulinum B Toxin	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)
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

Trial Locations

Locations (1)

University Hospital North Norway; 🇳🇴 Tromso, Norway