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

Phase 1

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: Botulinum Toxin Type A; Drug: Sodium chloride 9 mg/ml

• Registration Number: NCT02577185
• Lead Sponsor: LEO Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-09
• Study First Submitted QC: 2015-10-14
• Study First Posted: 2015-10-16
• Study Start: 2015-11
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-05
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
botulinum toxin type A	Botulinum Toxin Type A	Experimental drug
sodium chloride 9 mg/ml	Sodium chloride 9 mg/ml	Vehicle drug

Primary Outcome Measures

Name	Time	Method
Absolute change in Total Clinical Score (TCS) of clinical signs at 8 weeks after injection compared to baseline	8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in heart rate from baseline to week 8	8 weeks
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 8 compared to baseline	8 weeks
Absolute change in clinical score infiltration at week 1 compared to baseline	1 week
Change in blood pressure from baseline to week 8	8 weeks
Absolute change in clinical score scaling at week 4 compared to baseline	4 weeks
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

Trial Locations

Locations (2)

Hud- og Kønssygdomme, Aarhus Universitetshospital; 🇩🇰 Aarhus, Denmark

Hud- og allergiafdeling, Gentofte Hospital; 🇩🇰 Gentofte, Denmark