A Phase 1 interventional study of Botulinum Toxin Type A and Sodium chloride 9 mg/ml in Psoriasis Vulgaris, sponsored by LEO Pharma. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by LEO Pharma · Phase 1, Interventional, and Other
The purpose of this study is to evaluate the anti-psoriatic effect of injected Botulinum toxin type A compared to that of injected vehicle.
LEO Pharma is the lead sponsor of 225 studies on the registry; 5 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Experimental drug
Drug: Botulinum Toxin Type A
Vehicle drug
Drug: Sodium chloride 9 mg/ml
Absolute change in Total Clinical Score (TCS) of clinical signs at 8 weeks after injection compared to baseline
Time frame: 8 weeks
Absolute change in clinical score erythema at week 1 compared to baseline
Time frame: 1 week
Absolute change in clinical score erythema at week 3 compared to baseline
Time frame: 3 weeks
Absolute change in clinical score erythema at week 4 compared to baseline
Time frame: 4 weeks
Absolute change in clinical score erythema at week 8 compared to baseline
Time frame: 8 weeks
Absolute change in clinical score scaling at week 1 compared to baseline
Time frame: 1 week
Absolute change in clinical score scaling at week 3 compared to baseline
Time frame: 3 weeks
Absolute change in clinical score scaling at week 4 compared to baseline
Time frame: 4 weeks
Absolute change in clinical score scaling at week 8 compared to baseline
Time frame: 8 weeks
Absolute change in clinical score infiltration at week 1 compared to baseline
Time frame: 1 week
Absolute change in clinical score infiltration at week 3 compared to baseline
Time frame: 3 weeks
Absolute change in clinical score infiltration at week 4 compared to baseline
Time frame: 4 weeks
Absolute change in clinical score infiltration at week 8 compared to baseline
Time frame: 8 weeks
Absolute change in TCS at week 1 compared to baseline
Time frame: 1 week
Absolute change in TCS at week 3 compared to baseline
Time frame: 3 weeks
Absolute change in TCS at week 4 compared to baseline
Time frame: 4 weeks
Incidence of treatment emergent adverse events
Time frame: 10 weeks
Incidende of adverse events on the treated test sites
Time frame: 10 weeks
Incidence of adverse events leading to withdrawal from trial
Time frame: 8 weeks
Change in blood pressure from baseline to week 8
Time frame: 8 weeks
Change in heart rate from baseline to week 8
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A