Use of Botulinum Toxin to Treat Psoriasis

NCT00816517 | Completed Phase 1 DMC

• 1 other identifier: 0808M45282
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Vulgaris

Keywords

Psoriasis; Botulinum toxin

Outcome Measures

Primary Outcomes (1)

• psoriasis scoring scale

  baseline and 3months

Secondary Outcomes (1)

• 3mm skin biopsy.

  baseline and at 3 months.

Study Arms (1)

botulinum toxin

EXPERIMENTAL

injection of botulinum toxin type A

Biological: injection of botulinum toxin type A.

Interventions

injection of botulinum toxin type A. BIOLOGICAL

35 to 100 units injected around a skin lesion (plaque) one time.

Also known as: Botox.

botulinum toxin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• Allergan: collaborator

Study Sites (1)

Univerisity of Minnesota

Minneapolis, Minnesota, 55444, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Maria K Hordinsky, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2008
• First Posted: January 1, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 4, 2016

Record last verified: 2016-03

Locations

US (1)