A phase 4 multicenter, randomized, placebo-controlled Study evaluating the Effect of Apremilast on Pruritus and Quality of Life of Patients with moderate-to-severe Scalp Psoriasis
The scalp is the most frequently affected body region in psoriasis. Scalp Psoriasis can impair the quality of life greatly due to pruritus. This is however not usually investigated as a primary outcome of treatments. This study will investigate the effects of apremilast on the pruritus and quality of life and other patient reported outcomes in patients with scalp psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Anti-psoriatic drug
Indistinguishable tablets not containing apremilast, Placebo Oral Tablet
KSSG
Sankt Gallen, Canton of St. Gallen, Switzerland
Inselspital
Bern, Switzerland
CHUV
Lausanne, Switzerland
Department of Dermatology, University Hospital Zurich
Zurich, Switzerland
Scalp VAS Pruritus assessment
Pruritus VAS Scale (0 - 100)
Time frame: Weeks 16
Scalp VAS Pruritus assessment
Pruritus VAS Scale (0 - 100)
Time frame: Weeks 0, 4, 32, 52
% BSA
Body surface area
Time frame: Weeks 0, 4, 16, 32, 52
% BSA of scalp
Body surface area of scalp
Time frame: Weeks 0, 4, 16, 32, 52
PrecisePASI
Psoriasis Area and Severity Index, modified to measure in percentages
Time frame: Weeks 0, 4, 16, 32, 52
PGA
Physicians Global Assessment (0 - 5)
Time frame: Weeks 0, 4, 16, 32, 52
Scalp-PGA
Physicians Global Assessment of the Scalp (0 - 5)
Time frame: Weeks 0, 4, 16, 32, 52
DLQI
Skin related Quality of life (0 to 30)
Time frame: Weeks 0, 4, 16, 32, 52
Scalpdex
23 items related to scalp symptoms
Time frame: Weeks 0, 4, 16, 32, 52
PSSI
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Psoriasis score measuring intensity on the scalp
Time frame: Weeks 0, 4, 16, 32, 52
VAS pruritus assessment
Pruritus VAS Scale (0 - 100)
Time frame: Weeks 0, 4, 16, 32, 52
EQ-5D
Health-related Quality of Life Instrument
Time frame: Weeks 0, 4, 16, 32, 52