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

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Psoriasis Vulgaris

Treatments: Drug: Sodium chloride 9 mg/ml; Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02577185

EXP-1187

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

botulinum toxin type A

Experimental group

Description:

Experimental drug

Treatment:

Drug: Botulinum Toxin Type A

sodium chloride 9 mg/ml

Placebo Comparator group

Description:

Vehicle drug

Treatment:

Drug: Sodium chloride 9 mg/ml