Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis

Phase 4

• Conditions: Psoriasis of Scalp; Psoriasis Vulgaris
• Interventions: Drug: Apremilast 30mg; Drug: Placebo Oral Tablet

• Registration Number: NCT03553433
• Lead Sponsor: University of Zurich

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2018-04-18
• Status Verified: 2018-06
• Study Start: 2018-06
• Study First Submitted QC: 2018-06-11
• Last Update Submitted: 2018-06-11
• Study First Posted: 2018-06-12
• Last Update Posted: 2018-06-12
• Primary Completion: 2019-12
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum	Apremilast 30mg	Apremilast 30mg bd
Placebo Oral Tablet	Placebo Oral Tablet	Excipiens

Primary Outcome Measures

Name	Time	Method
Scalp VAS Pruritus assessment	Weeks 16	Pruritus VAS Scale (0 - 100)

Secondary Outcome Measures

Name	Time	Method
% BSA	Weeks 0, 4, 16, 32, 52	Body surface area
Scalp-PGA	Weeks 0, 4, 16, 32, 52	Physicians Global Assessment of the Scalp (0 - 5)
PGA	Weeks 0, 4, 16, 32, 52	Physicians Global Assessment (0 - 5)
PSSI	Weeks 0, 4, 16, 32, 52	Psoriasis score measuring intensity on the scalp
Scalp VAS Pruritus assessment	Weeks 0, 4, 32, 52	Pruritus VAS Scale (0 - 100)
PrecisePASI	Weeks 0, 4, 16, 32, 52	Psoriasis Area and Severity Index, modified to measure in percentages
% BSA of scalp	Weeks 0, 4, 16, 32, 52	Body surface area of scalp
DLQI	Weeks 0, 4, 16, 32, 52	Skin related Quality of life (0 to 30)
Scalpdex	Weeks 0, 4, 16, 32, 52	23 items related to scalp symptoms
VAS pruritus assessment	Weeks 0, 4, 16, 32, 52	Pruritus VAS Scale (0 - 100)
EQ-5D	Weeks 0, 4, 16, 32, 52	Health-related Quality of Life Instrument

Trial Locations

Locations (4)

CHUV; 🇨🇭 Lausanne, Switzerland

Department of Dermatology, University Hospital Zurich; 🇨🇭 Zurich, Switzerland

KSSG; 🇨🇭 Saint Gallen, SG, Switzerland

Inselspital; 🇨🇭 Bern, Switzerland