This is a multicenter, randomized, double-blinded,controlled clinical trial. The purpose of the study is to evaluate the efficacy and safety of Sulodexide versus placebo in preventing psoriasis recurrence in patients with plaque psoriasis who have discontinued biologic therapy after achieving clinical cure.
It was planned to include 160 patients with psoriasis vulgaris who met the inclusion criteria for discontinuation of biologics after reaching the standard of treatment and were randomised in a 1:1 ratio to receive oral treatment with sulodexide soft capsules or placebo capsules, respectively. 1. Sulodexide group: Starting after the last injection of secukinumab, oral treatment with sulodexide soft capsule (Alpha Weissmann Pharmaceuticals, Italy, approval number H20140119, specification 250 LSU) was given as 1 tab bid for 120 days or discontinued after judged to be a relapse; 2. Control group: Oral treatment with placebo capsule, 1 tab bid starting after the last injection of secukinumab, discontinued after 120 days of continuous oral administration or judged to be discontinued for relapse.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
160
Sulodexide group:Starting after the last injection of secukinumab, oral treatment with sulodexide soft capsule (Alpha Weissmann Pharmaceuticals, Italy, approval number H20140119, specification 250 LSU) was given as 1 tab bid for 120 days or discontinued after judged to be a relapse.
Control group: Oral treatment with placebo capsule, 1 tab bid starting after the last injection of secukinumab, discontinued after 120 days of continuous oral administration or judged to be discontinued for relapse.
xjjing Hospital
Xi'an, China
Time of appearance of the first psoriatic skin lesion
This outcome measures the duration (in days) from the start of the study intervention (sulodexide or placebo) until the first identifiable recurrence of a characteristic psoriatic skin lesion in participants who had previously achieved complete clearance (PASI 100) with secukinumab therapy.
Time frame: 1 year
Psoriasis lesion size and severity index score[PASI]
Psoriasis lesion size and severity index score
Time frame: 1 year
Dermatological Quality of Life Index[DLQI]
Dermatological Quality of Life Index
Time frame: 1 year
Self-Rating Anxiety Scale
The Self-Rating Anxiety Scale (SAS) is a validated 20-item questionnaire used to assess the severity of anxiety symptoms in participants. Each item is scored on a 4-point Likert scale (1 = "None or a little of the time" to 4 = "Most or all of the time"), with higher total scores indicating greater anxiety levels.
Time frame: 1 year
Self-Rating Depression Scale
The Self-Rating Depression Scale (SDS) is a widely used psychological assessment tool designed to measure the intensity and presence of depressive symptoms in individuals.
Time frame: 1 year
Adverse Events [AEs]
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.