Psoriasis VulgarisPhase 1NCT00816517
Use of Botulinum Toxin to Treat Psoriasis
A Phase 1 study testing injection of botulinum toxin type A. in people with Psoriasis Vulgaris, run by University of Minnesota at 1 site in United States.
Trial summary
Psoriasis vulgaris is a chronic disease in which psoriatic plaques may appear on the knees, elbows, scalp and trunk. Evidence suggests the role of neurogenic inflammation in the pathogenesis of psoriasis. Botulinum toxin has been shown to have an effect on inhibiting neurogenic inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- injection of botulinum toxin type A.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2015
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy subjects. Psoriasis vulgaris diagnosis made by a board certified dermatologist involving at least one area that has been intolerant or recalcitrant to at least two forms of recognized topical or systemic treatments in the past. In addition, the subject should have at least a score of 2 for keratoderma and erythema. Signed informed consent. Willing to adhere to protocol.
Who cannot join
- Immunosuppressed patients, pregnant, secondary skin infections, phototherapy within 4 weeks of the botulinum toxin injection, exposure to any topical or systemic retinoid treatment with the last 12 months, volunteers taking chloroquine and hydroxychloroquine, volunteers on warfarin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univerisity of Minnesota
Minneapolis, Minnesota, 55444
About this study
Official title: Pilot Study on the Safety and Efficacy of Botulinum Toxin Injections in the Treatment of Psoriasis Vulgaris.
Psoriasis vulgaris is a chronic disease in which psoriatic plaques may appear on the knees, elbows, scalp and trunk. Evidence suggests the role of neurogenic inflammation in the pathogenesis of psoriasis. Botulinum toxin has been shown to have an effect on inhibiting neurogenic inflammation.
Recently, it was reported that patients who suffered from dystonia and had concomitant psoriasis, when treated with botulinum toxin for dystonia noted a dramatic improvement of their psoriatic lesions.
This pilot study will determine the safety and efficacy of botulinum toxin in the management of psoriasis vulgaris.
- Conditions
- Psoriasis Vulgaris
- Being tested
- injection of botulinum toxin type A.
- Keywords
- Psoriasis, Botulinum toxin
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of botulinum toxin type A.Biological
Also called Botox.
35 to 100 units injected around a skin lesion (plaque) one time.
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin | Experimental | injection of botulinum toxin type A Receives: Biological: injection of botulinum toxin type A. |
What is being measured
The primary outcome is the main question the study is designed to answer.
psoriasis scoring scale
Measured: baseline and 3months
Secondary outcomes (1)
3mm skin biopsy.
Measured: baseline and at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Maria K Hordinsky, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816517
- Sponsor's protocol ID
- 0808M45282
- Status last verified
- Mar 2016
- First submitted
- 31 Dec 2008
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Safety and Efficacy of Botulinum Toxin Injections in the Treatment of Psoriasis Vulgaris.
- ClinicalTrials.gov ID
- NCT00816517
- Acronym / sponsor ID
- 0808M45282
- Conditions
- Psoriasis Vulgaris
- Keywords
- Psoriasis, Botulinum toxin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jan 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Jan 2009 (estimated)
- 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.
Psoriasis vulgaris is a chronic disease in which psoriatic plaques may appear on the knees, elbows, scalp and trunk. Evidence suggests the role of neurogenic inflammation in the pathogenesis of psoriasis. Botulinum toxin has been shown to have an effect on inhibiting neurogenic inflammation.
Recently, it was reported that patients who suffered from dystonia and had concomitant psoriasis, when treated with botulinum toxin for dystonia noted a dramatic improvement of their psoriatic lesions.
This pilot study will determine the safety and efficacy of botulinum toxin in the management of psoriasis vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin | Experimental | Biological: injection of botulinum toxin type A.injection of botulinum toxin type A |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects. Psoriasis vulgaris diagnosis made by a board certified dermatologist involving at least one area that has been intolerant or recalcitrant to at least two forms of recognized topical or systemic treatments in the past. In addition, the subject should have at least a score of 2 for keratoderma and erythema. Signed informed consent. Willing to adhere to protocol.
Key exclusion criteria (1 listed)
- Immunosuppressed patients, pregnant, secondary skin infections, phototherapy within 4 weeks of the botulinum toxin injection, exposure to any topical or systemic retinoid treatment with the last 12 months, volunteers taking chloroquine and hydroxychloroquine, volunteers on warfarin.
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 |
|---|---|---|
| injection of botulinum toxin type A.Also: Botox.35 to 100 units injected around a skin lesion (plaque) one time. | Biological | botulinum toxin |
Primary outcome
psoriasis scoring scale
Time frame: baseline and 3months
1 secondary outcome
3mm skin biopsy.
Time frame: baseline and at 3 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 4 Apr 2016.
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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.
Maria K Hordinsky, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing injection of botulinum toxin type A. in people with Psoriasis Vulgaris, run by University of Minnesota at 1 site in United States.
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 1 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 4 Apr 2016. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
psoriasis scoring scale (time frame: baseline and 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2016.