Use of Botulinum Toxin to Treat Psoriasis

NCT ID: NCT00816517

Last Updated: 2016-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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botulinum toxin

injection of botulinum toxin type A

Group Type EXPERIMENTAL

injection of botulinum toxin type A.

Intervention Type BIOLOGICAL

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

Interventions

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injection of botulinum toxin type A.

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Botox.

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria K Hordinsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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Univerisity of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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0808M45282

Identifier Type: -

Identifier Source: org_study_id

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