Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103074
• Other study ID #: 2017/149 (REK)
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: September 23, 2018

Study information

• Verified date: October 2018
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 23, 2018
• Est. primary completion date: March 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• Botulinum B Toxin
Intradermal injections

Other:
• Placebo Saline
Intradermal injections

Locations

Country	Name	City	State
Norway	University Hospital North Norway	Tromso

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital of North Norway	Hidrosis Clinic, Stockholm, Sweden, The Royal Norwegian Ministry of Health

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported improvement after invention with Botulinum toxin B	Outcome measured by Dermatological Life Quality Index (DLQI)-scores	End point analysis 6 months
Secondary	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)	Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months
Secondary	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	Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months
Secondary	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)	Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months