Psoriasis Vulgaris
Conditions
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.
Interventions
DRUGBotulinum Toxin Type A
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change in Total Clinical Score (TCS) of clinical signs at 8 weeks after injection compared to baseline | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change in clinical score erythema at week 3 compared to baseline | 3 weeks |
| Absolute change in clinical score erythema at week 4 compared to baseline | 4 weeks |
| Absolute change in clinical score erythema at week 8 compared to baseline | 8 weeks |
| Absolute change in clinical score scaling at week 1 compared to baseline | 1 week |
| Absolute change in clinical score scaling at week 3 compared to baseline | 3 weeks |
| Absolute change in clinical score scaling at week 4 compared to baseline | 4 weeks |
| Absolute change in clinical score scaling at week 8 compared to baseline | 8 weeks |
| Absolute change in clinical score infiltration at week 1 compared to baseline | 1 week |
| Absolute change in clinical score infiltration at week 3 compared to baseline | 3 weeks |
| Absolute change in clinical score erythema at week 1 compared to baseline | 1 week |
| Absolute change in clinical score infiltration at week 8 compared to baseline | 8 weeks |
| Absolute change in TCS at week 1 compared to baseline | 1 week |
| Absolute change in TCS at week 3 compared to baseline | 3 weeks |
| Absolute change in TCS at week 4 compared to baseline | 4 weeks |
| Incidence of treatment emergent adverse events | 10 weeks |
| Incidende of adverse events on the treated test sites | 10 weeks |
| Incidence of adverse events leading to withdrawal from trial | 8 weeks |
| Change in blood pressure from baseline to week 8 | 8 weeks |
| Change in heart rate from baseline to week 8 | 8 weeks |
| Absolute change in clinical score infiltration at week 4 compared to baseline | 4 weeks |
Countries
Denmark
Outcome results
None listed