Clinical trial NCT03103074: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hidradenitis Suppurativa
Keywords: botulinum toxin
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
name: Hidrosis Clinic, Stockholm, Sweden
First posted: 2017-04-06
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: First treatment - one placebo and one active substance group Thereafter - all patients receive active substance
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patient reported improvement after invention with Botulinum toxin B
timeFrame: End point analysis 6 months
Secondary outcomes:
measure: Identification of clinical subgroups with best response to intervention as assessed by clinically scored measures
timeFrame: Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months
measure: Identify if covariates such as age, disease duration, smoking state, BMI and sweating influence patient reported improvement
timeFrame: Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months
measure: Identification of clinical subgroups with best response to intervention as assessed by patient reported improvement
timeFrame: Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months
Other outcomes:
Locations:
city: Tromso
country: Norway
facility: University Hospital North Norway
Study officials:
affiliation: Consultant NEHR-HUD/Postdoc
name: Øystein Grimstad, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.