The purpose of this study is to evaluate the anti-psoriatic effect of injected Botulinum toxin type A compared to that of injected vehicle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
10
Hud- og Kønssygdomme, Aarhus Universitetshospital
Aarhus, Denmark
Hud- og allergiafdeling, Gentofte Hospital
Gentofte Municipality, Denmark
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
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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