Hidradenitis SuppurativaNCT03103074
Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa
A study testing Botulinum B Toxin in people with Hidradenitis Suppurativa, run by University Hospital of North Norway at 1 site in Norway.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Botulinum B Toxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2017to 23 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Placebo Controlled Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa
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
Read the 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Botulinum B Toxin, Placebo Saline
- Keywords
- botulinum toxin
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum B ToxinDrug
Also called Neurobloc
Intradermal injections
Placebo SalineOther
Also called Saline (NaCl 0,9%)
Intradermal injections
| Study group | Role | What they receive |
|---|---|---|
| Botulinum B Toxin | Experimental | 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 Receives: Drug: Botulinum B Toxin |
| Placebo | Placebo comparator | 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 Receives: Other: Placebo Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported improvement after invention with Botulinum toxin B
Outcome measured by Dermatological Life Quality Index (DLQI)-scores
Measured: End point analysis 6 months
Secondary outcomes (3)
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)
Measured: Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months
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
Measured: Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months
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)
Measured: Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start1 Jun 2017
- Primary completion23 Mar 2018
- Study completion23 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- First treatment - one placebo and one active substance group Thereafter - all patients receive active substance
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health, Hidrosis Clinic, Stockholm, Sweden
- Responsible party
- Principal investigator, Øystein Grimstad, University Hospital of North Norway
- Investigators
- Øystein Grimstad, MD PhD, Principal investigator, Consultant NEHR-HUD/Postdoc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103074
- Sponsor's protocol ID
- 2017/149 (REK)
- Status last verified
- Oct 2018
- First submitted
- 17 Mar 2017
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32761500
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Placebo Controlled Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT03103074
- Acronym / sponsor ID
- 2017/149 (REK)
- Conditions
- Hidradenitis Suppurativa
- Keywords
- botulinum toxin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health, Hidrosis Clinic, Stockholm, Sweden
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 23 Sep 2018 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- First treatment - one placebo and one active substance group Thereafter - all patients receive active substance
| Arm | Type | Receives |
|---|---|---|
| Botulinum B Toxin | Experimental | Drug: Botulinum B ToxinBotulinum 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 |
| Placebo | Placebo comparator | Other: Placebo SalineSaline (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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum B ToxinAlso: NeuroblocIntradermal injections | Drug | Botulinum B Toxin |
| Placebo SalineAlso: Saline (NaCl 0,9%)Intradermal injections | Other | Placebo |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Derived from this study: PubMed 32761500Grimstad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øystein Grimstad, MD PhD principal investigator
Consultant NEHR-HUD/Postdoc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum B Toxin in people with Hidradenitis Suppurativa, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported improvement after invention with Botulinum toxin B (time frame: End point analysis 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03103074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.