Back to resultsUse of Botulinum Toxin to Treat Psoriasis
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
injection of botulinum toxin type A.
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Psoriasis, Botulinum toxin
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Univerisity of Minnesota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
botulinum toxin
Arm Description
injection of botulinum toxin type A
Outcomes
Primary Outcome Measures
psoriasis scoring scale
Secondary Outcome Measures
3mm skin biopsy.
Full Information
NCT ID
NCT00816517
First Posted
December 31, 2008
Last Updated
March 31, 2016
Sponsor
University of Minnesota
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT00816517
Brief Title
Use of Botulinum Toxin to Treat Psoriasis
Official Title
Pilot Study on the Safety and Efficacy of Botulinum Toxin Injections in the Treatment of Psoriasis Vulgaris.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
Keywords
Psoriasis, Botulinum toxin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulinum toxin
Arm Type
Experimental
Arm Description
injection of botulinum toxin type A
Intervention Type
Biological
Intervention Name(s)
injection of botulinum toxin type A.
Other Intervention Name(s)
Botox.
Intervention Description
35 to 100 units injected around a skin lesion (plaque) one time.
Primary Outcome Measure Information:
Title
psoriasis scoring scale
Time Frame
baseline and 3months
Secondary Outcome Measure Information:
Title
3mm skin biopsy.
Time Frame
baseline and at 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria K Hordinsky, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univerisity of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55444
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of Botulinum Toxin to Treat Psoriasis
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