An Exploratory Trial Investigating the Neurogenic Compone... | NCT02577185

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

NCT02577185

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Feb 24, 2025Actual

Enrollment

10Actual

Phase

Phase 1

Conditions

Psoriasis Vulgaris

Interventions

Botulinum Toxin Type A
Sodium chloride 9 mg/ml

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Oct 9, 2015

First Submission Date that Met QC Criteria

Oct 14, 2015

First Posted Date

Oct 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2025

Last Update Posted Date

Feb 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
botulinum toxin type A	Experimental	Experimental drug	Drug: Botulinum Toxin Type A
sodium chloride 9 mg/ml	Placebo Comparator	Vehicle drug	Drug: Sodium chloride 9 mg/ml

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum Toxin Type A	Drug		botulinum toxin type A
Sodium chloride 9 mg/ml

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Iversen, MD	Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hud- og Kønssygdomme, Aarhus Universitetshospital		Aarhus		8000	Denmark
Hud- og allergiafdeling, Gentofte Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided