Skip to main content
OpenTrials
Completed

NCT Number: NCT02577185

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psoriasis Vulgaris

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hud- og Kønssygdomme, Aarhus Universitetshospital, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

Sodium Chloride 9 mg/ml

Drug

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

  1. Absolute change in clinical score erythema at week 1 compared to baseline

    Time frame: 1 week

  2. Absolute change in clinical score erythema at week 3 compared to baseline

    Time frame: 3 weeks

  3. Absolute change in clinical score erythema at week 4 compared to baseline

    Time frame: 4 weeks

  4. Absolute change in clinical score erythema at week 8 compared to baseline

    Time frame: 8 weeks

  5. Absolute change in clinical score scaling at week 1 compared to baseline

    Time frame: 1 week

  6. Absolute change in clinical score scaling at week 3 compared to baseline

    Time frame: 3 weeks

  7. Absolute change in clinical score scaling at week 4 compared to baseline

    Time frame: 4 weeks

  8. Absolute change in clinical score scaling at week 8 compared to baseline

    Time frame: 8 weeks

  9. Absolute change in clinical score infiltration at week 1 compared to baseline

    Time frame: 1 week

  10. Absolute change in clinical score infiltration at week 3 compared to baseline

    Time frame: 3 weeks

  11. Absolute change in clinical score infiltration at week 4 compared to baseline

    Time frame: 4 weeks

  12. Absolute change in clinical score infiltration at week 8 compared to baseline

    Time frame: 8 weeks

  13. Absolute change in TCS at week 1 compared to baseline

    Time frame: 1 week

  14. Absolute change in TCS at week 3 compared to baseline

    Time frame: 3 weeks

  15. Absolute change in TCS at week 4 compared to baseline

    Time frame: 4 weeks

  16. Incidence of treatment emergent adverse events

    Time frame: 10 weeks

  17. Incidende of adverse events on the treated test sites

    Time frame: 10 weeks

  18. Incidence of adverse events leading to withdrawal from trial

    Time frame: 8 weeks

  19. Change in blood pressure from baseline to week 8

    Time frame: 8 weeks

  20. Change in heart rate from baseline to week 8

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 16, 2015
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.