Use of Botulinum Toxin to Treat Psoriasis
This study is currently recruiting participants.
Verified October 2012 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborator:
Allergan
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00816517
First received: December 31, 2008
Last updated: October 22, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis Vulgaris |
Biological: injection of botulinum toxin type A. |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study on the Safety and Efficacy of Botulinum Toxin Injections in the Treatment of Psoriasis Vulgaris. |
Resource links provided by NLM:
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- psoriasis scoring scale [ Time Frame: baseline and 3months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 3mm skin biopsy. [ Time Frame: baseline and at 3 months. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: botulinum toxin
injection of botulinum toxin type A
|
Biological: injection of botulinum toxin type A.
35 to 100 units injected around a skin lesion (plaque) one time.
Other Name: Botox.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816517
Contacts
| Contact: Ioanna Panoutsopoulou, MD | 612-625-8625 | panou001@umn.edu |
Locations
| United States, Minnesota | |
| Univerisity of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55444 | |
| Principal Investigator: Maria K Hordinsky, MD | |
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Allergan
Investigators
| Principal Investigator: | Maria K Hordinsky, MD | University of Minnesota - Clinical and Translational Science Institute |
More Information
No publications provided
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00816517 History of Changes |
| Other Study ID Numbers: | 0808M45282 |
| Study First Received: | December 31, 2008 |
| Last Updated: | October 22, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
|
Psoriasis Botulinum toxin |
Additional relevant MeSH terms:
|
Botulinum Toxins, Type A Botulinum Toxins Psoriasis Skin Diseases, Papulosquamous Skin Diseases Neuromuscular Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013