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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577185
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: Botulinum Toxin Type A Drug: Sodium chloride 9 mg/ml Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
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 Start Date : November 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Psoriasis

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



Primary Outcome Measures :
  1. Absolute change in Total Clinical Score (TCS) of clinical signs at 8 weeks after injection compared to baseline [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577185


Locations
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Denmark
Hud- og Kønssygdomme, Aarhus Universitetshospital
Aarhus, Denmark, 8000
Hud- og allergiafdeling, Gentofte Hospital
Gentofte, Denmark, 2900
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Lars Iversen, MD Aarhus Universitetshospital
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02577185    
Other Study ID Numbers: EXP-1187
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents