Hidradenitis Suppurativa
Conditions
Keywords
botulinum toxin
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.
Interventions
DRUGBotulinum B Toxin
Intradermal injections
OTHERPlacebo Saline
Intradermal injections
Sponsors
The Royal Norwegian Ministry of Health
Hidrosis Clinic, Stockholm, Sweden
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Partcipant and investigator/outcomes assessor are blinded. Treatment will be given after randomization by a secondary investigator.
Intervention model description
First treatment - one placebo and one active substance group Thereafter - all patients receive active substance
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported improvement after invention with Botulinum toxin B | End point analysis 6 months | Outcome measured by Dermatological Life Quality Index (DLQI)-scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Countries
Norway
Outcome results
None listed