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

Study Overview
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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.

Official Title
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An Exploratory Psoriasis Plaque Test Trial Investigating the Neurogenic Component in Psoriasis Vulgaris by Use of Botulinum Toxin A as Tool Compound

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: Botulinum Toxin Type A
* Drug: Sodium chloride 9 mg/ml


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: botulinum toxin type A<br>Experimental drug | Drug: Botulinum Toxin Type A<br> <br> |
| Placebo Comparator: sodium chloride 9 mg/ml<br>Vehicle drug | Drug: Sodium chloride 9 mg/ml<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in Total Clinical Score (TCS) of clinical signs at 8 weeks after injection compared to baseline |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in clinical score erythema at week 1 compared to baseline |  | 1 week | 
| Absolute change in clinical score erythema at week 3 compared to baseline |  | 3 weeks | 
| Absolute change in clinical score erythema at week 4 compared to baseline |  | 4 weeks | 
| Absolute change in clinical score erythema at week 8 compared to baseline |  | 8 weeks | 
| Absolute change in clinical score scaling at week 1 compared to baseline |  | 1 week | 
| Absolute change in clinical score scaling at week 3 compared to baseline |  | 3 weeks | 
| Absolute change in clinical score scaling at week 4 compared to baseline |  | 4 weeks | 
| Absolute change in clinical score scaling at week 8 compared to baseline |  | 8 weeks | 
| Absolute change in clinical score infiltration at week 1 compared to baseline |  | 1 week | 
| Absolute change in clinical score infiltration at week 3 compared to baseline |  | 3 weeks | 
| Absolute change in clinical score infiltration at week 4 compared to baseline |  | 4 weeks | 
| Absolute change in clinical score infiltration at week 8 compared to baseline |  | 8 weeks | 
| Absolute change in TCS at week 1 compared to baseline |  | 1 week | 
| Absolute change in TCS at week 3 compared to baseline |  | 3 weeks | 
| Absolute change in TCS at week 4 compared to baseline |  | 4 weeks | 
| Incidence of treatment emergent adverse events |  | 10 weeks | 
| Incidende of adverse events on the treated test sites |  | 10 weeks | 
| Incidence of adverse events leading to withdrawal from trial |  | 8 weeks | 
| Change in blood pressure from baseline to week 8 |  | 8 weeks | 
| Change in heart rate from baseline to week 8 |  | 8 weeks |