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

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sodium chloride 9 mg/ml
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hud- og Kønssygdomme, Aarhus Universitetshospital
  • Hud- og allergiafdeling, Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

botulinum toxin type A

sodium chloride 9 mg/ml

Arm Description

Experimental drug

Vehicle drug

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 9, 2015
Last Updated
May 8, 2017
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02577185
Brief Title
An Exploratory Trial Investigating the Neurogenic Component in Psoriasis Vulgaris by Use of Botulinum Toxin A
Official Title
An Exploratory Psoriasis Plaque Test Trial Investigating the Neurogenic Component in Psoriasis Vulgaris by Use of Botulinum Toxin A as Tool Compound
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
botulinum toxin type A
Arm Type
Experimental
Arm Description
Experimental drug
Arm Title
sodium chloride 9 mg/ml
Arm Type
Placebo Comparator
Arm Description
Vehicle drug
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Intervention Type
Drug
Intervention Name(s)
Sodium chloride 9 mg/ml
Primary Outcome Measure Information:
Title
Absolute change in Total Clinical Score (TCS) of clinical signs at 8 weeks after injection compared to baseline
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Absolute change in clinical score erythema at week 1 compared to baseline
Time Frame
1 week
Title
Absolute change in clinical score erythema at week 3 compared to baseline
Time Frame
3 weeks
Title
Absolute change in clinical score erythema at week 4 compared to baseline
Time Frame
4 weeks
Title
Absolute change in clinical score erythema at week 8 compared to baseline
Time Frame
8 weeks
Title
Absolute change in clinical score scaling at week 1 compared to baseline
Time Frame
1 week
Title
Absolute change in clinical score scaling at week 3 compared to baseline
Time Frame
3 weeks
Title
Absolute change in clinical score scaling at week 4 compared to baseline
Time Frame
4 weeks
Title
Absolute change in clinical score scaling at week 8 compared to baseline
Time Frame
8 weeks
Title
Absolute change in clinical score infiltration at week 1 compared to baseline
Time Frame
1 week
Title
Absolute change in clinical score infiltration at week 3 compared to baseline
Time Frame
3 weeks
Title
Absolute change in clinical score infiltration at week 4 compared to baseline
Time Frame
4 weeks
Title
Absolute change in clinical score infiltration at week 8 compared to baseline
Time Frame
8 weeks
Title
Absolute change in TCS at week 1 compared to baseline
Time Frame
1 week
Title
Absolute change in TCS at week 3 compared to baseline
Time Frame
3 weeks
Title
Absolute change in TCS at week 4 compared to baseline
Time Frame
4 weeks
Title
Incidence of treatment emergent adverse events
Time Frame
10 weeks
Title
Incidende of adverse events on the treated test sites
Time Frame
10 weeks
Title
Incidence of adverse events leading to withdrawal from trial
Time Frame
8 weeks
Title
Change in blood pressure from baseline to week 8
Time Frame
8 weeks
Title
Change in heart rate from baseline to week 8
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Iversen, MD
Organizational Affiliation
Aarhus Universitetshospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hud- og Kønssygdomme, Aarhus Universitetshospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Hud- og allergiafdeling, Gentofte Hospital
City
Gentofte
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

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

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