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

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577185
• Other study ID #: EXP-1187
• Status: Completed
• Phase: Phase 1
• First received: October 9, 2015
• Last updated: May 8, 2017
• Start date: November 2015
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Botulinum Toxin Type A

• Sodium chloride 9 mg/ml

Locations

Country	Name	City	State
Denmark	Hud- og Kønssygdomme, Aarhus Universitetshospital	Aarhus
Denmark	Hud- og allergiafdeling, Gentofte Hospital	Gentofte

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in Total Clinical Score (TCS) of clinical signs at 8 weeks after injection compared to baseline		8 weeks
Secondary	Absolute change in clinical score erythema at week 1 compared to baseline		1 week
Secondary	Absolute change in clinical score erythema at week 3 compared to baseline		3 weeks
Secondary	Absolute change in clinical score erythema at week 4 compared to baseline		4 weeks
Secondary	Absolute change in clinical score erythema at week 8 compared to baseline		8 weeks
Secondary	Absolute change in clinical score scaling at week 1 compared to baseline		1 week
Secondary	Absolute change in clinical score scaling at week 3 compared to baseline		3 weeks
Secondary	Absolute change in clinical score scaling at week 4 compared to baseline		4 weeks
Secondary	Absolute change in clinical score scaling at week 8 compared to baseline		8 weeks
Secondary	Absolute change in clinical score infiltration at week 1 compared to baseline		1 week
Secondary	Absolute change in clinical score infiltration at week 3 compared to baseline		3 weeks
Secondary	Absolute change in clinical score infiltration at week 4 compared to baseline		4 weeks
Secondary	Absolute change in clinical score infiltration at week 8 compared to baseline		8 weeks
Secondary	Absolute change in TCS at week 1 compared to baseline		1 week
Secondary	Absolute change in TCS at week 3 compared to baseline		3 weeks
Secondary	Absolute change in TCS at week 4 compared to baseline		4 weeks
Secondary	Incidence of treatment emergent adverse events		10 weeks
Secondary	Incidende of adverse events on the treated test sites		10 weeks
Secondary	Incidence of adverse events leading to withdrawal from trial		8 weeks
Secondary	Change in blood pressure from baseline to week 8		8 weeks
Secondary	Change in heart rate from baseline to week 8		8 weeks