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OpenTrials
Completed

NCT Number: NCT00816517

Use of Botulinum Toxin to Treat Psoriasis

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.

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Key information

Conditions

Psoriasis Vulgaris Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Univerisity of Minnesota

Minneapolis, Minnesota, 55444, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

injection of botulinum toxin type A.

Biological

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

Other names: Botox.

Primary outcomes

  1. psoriasis scoring scale

    Time frame: baseline and 3months

Secondary outcomes

  1. 3mm skin biopsy.

    Time frame: baseline and at 3 months.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Allergan

Registry information

Official study title

Pilot Study on the Safety and Efficacy of Botulinum Toxin Injections in the Treatment of Psoriasis Vulgaris.

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jan 1, 2009
Registry last updated
Apr 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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