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

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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botulinum toxin type A

Experimental drug

Group Type EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type DRUG

sodium chloride 9 mg/ml

Vehicle drug

Group Type PLACEBO_COMPARATOR

Sodium chloride 9 mg/ml

Intervention Type DRUG

Interventions

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Botulinum Toxin Type A

Intervention Type DRUG

Sodium chloride 9 mg/ml

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No