A Prospective Photographic Analysis Of Psoriasis Severity Following Treatment With Tildrakizumab

Not Applicable

• Conditions: Skin - Dermatological conditions; Psoriasis

• Registration Number: ACTRN12620001307998
• Lead Sponsor: Samson Clinical Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-02
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

i) Adults (aged 18 years and above) who are eligible for systemic therapy or phototherapy.
ii) Moderate to severe plaque psoriasis with a PASI equal 15 and BSA equal 10%
iii) Minimum diagnosis of 6 months prior to Baseline
iv) Active plaque psoriasis present for at least 6 months from initial diagnosis
v) Failed to achieve an adequate response based on PASI assessment, contraindicated or intolerant to at least 3 of 4 systemic treatments for plaque psoriasis.

Exclusion Criteria

i) Previous/current treatment with IL23.
ii) Previous exposure to other biologics agents
iii) Diagnosis of other forms of psoriasis other than plaque psoriasis
iv) Pregnant or lactating women (Female participants who are pregnant, planning a pregnancy or nursing a child or not on an acceptable and highly effective birth control method)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in psoriasis severity in patients, will be assessed and documented through photographic analysis of lesions with whole body 3-D photography using Canfield Vectra WB360. [Weeks 0 (baseline), 4, 8, 16, 28, 40, 52 and 64. ]

Secondary Outcome Measures

Name	Time	Method
Composite secondary outcome:<br><br>Changes in psoriasis severity in patients, will be assessed and documented through PASI assessment and physical examination by trained investigator.<br><br>[Weeks 0 (baseline), 4, 8, 16, 28, 40, 52 and 64. ];Assess the subjective impact of psoriasis treatment with Tildrakizumab, through patient responses to Dermatology Life Quality Index (DLQI). [Weeks 0 (baseline), 4, 8, 16, 28, 40, 52 and 64. ]