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Trial record 10 of 54 for:    "hidradenitis suppurativa" OR "acne inversa"

Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

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ClinicalTrials.gov Identifier: NCT03103074
Recruitment Status : Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : November 7, 2017
Sponsor:
Collaborators:
The Royal Norwegian Ministry of Health
Hidrosis Clinic, Stockholm, Sweden
Information provided by (Responsible Party):
Øystein Grimstad, 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

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: Botulinum B Toxin Other: Placebo Saline Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: First treatment - one placebo and one active substance group Thereafter - all patients receive active substance
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Partcipant and investigator/outcomes assessor are blinded. Treatment will be given after randomization by a secondary investigator.
Primary Purpose: Treatment
Official Title: Randomized Double Blind Placebo Controlled Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : March 23, 2018
Estimated Study Completion Date : September 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Botulinum B Toxin
Intradermal injections
Other Name: Neurobloc

Placebo Comparator: Placebo
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
Intradermal injections
Other Name: Saline (NaCl 0,9%)




Primary Outcome Measures :
  1. Patient reported improvement after invention with Botulinum toxin B [ Time Frame: End point analysis 6 months ]
    Outcome measured by Dermatological Life Quality Index (DLQI)-scores


Secondary Outcome Measures :
  1. Identification of clinical subgroups with best response to intervention as assessed by clinically scored measures [ Time Frame: 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)

  2. Identify if covariates such as age, disease duration, smoking state, BMI and sweating influence patient reported improvement [ Time Frame: 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

  3. Identification of clinical subgroups with best response to intervention as assessed by patient reported improvement [ Time Frame: 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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103074


Locations
Norway
University Hospital North Norway
Tromso, Norway, 9038
Sponsors and Collaborators
University Hospital of North Norway
The Royal Norwegian Ministry of Health
Hidrosis Clinic, Stockholm, Sweden
Investigators
Principal Investigator: Øystein Grimstad, MD PhD Consultant NEHR-HUD/Postdoc

Responsible Party: Øystein Grimstad, Md PhD, University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT03103074     History of Changes
Other Study ID Numbers: 2017/149 (REK)
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Øystein Grimstad, University Hospital of North Norway:
botulinum toxin

Additional relevant MeSH terms:
Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Botulinum Toxins
rimabotulinumtoxinB
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Dyskinesia Agents
Neuromuscular Agents
Peripheral Nervous System Agents