An Exploratory Trial Investigating the Neurogenic Component in Psoriasis Vulgaris by Use of Botulinum Toxin A

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the anti-psoriatic effect of injected Botulinum toxin type A compared to that of injected vehicle.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Age 18 years or above

• A diagnosis of psoriasis vulgaris with lesions located on arms and/or legs and/or trunk

• Chronic stable psoriasis vulgaris diagnosed more than 6 months prior to screening.

• Women must use a reliable contraceptive during the trial.

Exclusion Criteria:

• Pregnant or breast feeding women, or women planning to become pregnant.

• Skin infection at injection sites

• Use of biological therapies or small molecules (marketed or not marketed) with a possible effect on psoriasis vulgaris

• Use of systemic treatments with a potential effect on psoriasis vulgaris

• Exposure to phototherapy within 4 weeks for PUVA and 2 weeks for UVB prior to Randomisation

• Use of potent or very potent (WHO group III-IV) corticosteroids for topical treatment of psoriasis within a 4 week period prior to randomisation

• Use of muscle relaxants

• History of dysphagia or aspiration

• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis