Clinical trial NCT02577185: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-10-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Absolute change in Total Clinical Score (TCS) of clinical signs at 8 weeks after injection compared to baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: Absolute change in clinical score erythema at week 1 compared to baseline
timeFrame: 1 week
measure: Absolute change in clinical score erythema at week 3 compared to baseline
timeFrame: 3 weeks
measure: Absolute change in clinical score erythema at week 4 compared to baseline
timeFrame: 4 weeks
measure: Absolute change in clinical score erythema at week 8 compared to baseline
timeFrame: 8 weeks
measure: Absolute change in clinical score scaling at week 1 compared to baseline
timeFrame: 1 week
measure: Absolute change in clinical score scaling at week 3 compared to baseline
timeFrame: 3 weeks
measure: Absolute change in clinical score scaling at week 4 compared to baseline
timeFrame: 4 weeks
measure: Absolute change in clinical score scaling at week 8 compared to baseline
timeFrame: 8 weeks
measure: Absolute change in clinical score infiltration at week 1 compared to baseline
timeFrame: 1 week
measure: Absolute change in clinical score infiltration at week 3 compared to baseline
timeFrame: 3 weeks
measure: Absolute change in clinical score infiltration at week 4 compared to baseline
timeFrame: 4 weeks
measure: Absolute change in clinical score infiltration at week 8 compared to baseline
timeFrame: 8 weeks
measure: Absolute change in TCS at week 1 compared to baseline
timeFrame: 1 week
measure: Absolute change in TCS at week 3 compared to baseline
timeFrame: 3 weeks
measure: Absolute change in TCS at week 4 compared to baseline
timeFrame: 4 weeks
measure: Incidence of treatment emergent adverse events
timeFrame: 10 weeks
measure: Incidende of adverse events on the treated test sites
timeFrame: 10 weeks
measure: Incidence of adverse events leading to withdrawal from trial
timeFrame: 8 weeks
measure: Change in blood pressure from baseline to week 8
timeFrame: 8 weeks
measure: Change in heart rate from baseline to week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Hud- og Kønssygdomme, Aarhus Universitetshospital
city: Gentofte
country: Denmark
facility: Hud- og allergiafdeling, Gentofte Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Lars Iversen, MD
role: PRINCIPAL_INVESTIGATOR
References: