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

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Botulinum Toxin Type A; Drug: Sodium chloride 9 mg/ml

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Hud- og Kønssygdomme, Aarhus Universitetshospital
  • Gentofte, Denmark, 2900
    • Hud- og allergiafdeling, Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Lars Iversen, MD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 9, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimated): October 16, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Neuromuscular Agents; Acetylcholine Release Inhibitors; Botulinum Toxins, Type A; abobotulinumtoxinA; Botulinum Toxins
• Other Study ID Numbers: EXP-1187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO