Trial record 14 of 162 for:    Open Studies | botulinum toxin

Use of Botulinum Toxin to Treat Psoriasis

This study is currently recruiting participants.
Verified November 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
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: November 20, 2013
Last verified: November 2013
  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: December 2014
Estimated Primary Completion Date: June 2014 (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: November 20, 2013
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 April 15, 2014