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Use of Botulinum Toxin to Treat Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816517
First Posted: January 1, 2009
Last Update Posted: April 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • 3mm skin biopsy. [ Time Frame: baseline and at 3 months. ]

Enrollment: 8
Study Start Date: January 2009
Study Completion Date: December 2015
Primary Completion Date: June 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT00816517


Locations
United States, Minnesota
Univerisity of Minnesota
Minneapolis, Minnesota, United States, 55444
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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00816517     History of Changes
Other Study ID Numbers: 0808M45282
First Submitted: December 31, 2008
First Posted: January 1, 2009
Last Update Posted: April 4, 2016
Last Verified: March 2016

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Psoriasis
Botulinum toxin

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents