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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulodexide Group | Experimental | Participants in this group will receive oral sulodexide soft capsules (manufactured by Alfa Wassermann, Italy; approval number H20140119, specification 250 LSU) after discontinuing secukinumab. The dosing regimen is 1 capsule twice daily for 120 consecutive days or until psoriasis relapse is confirmed. Sulodexide, a vascular protective agent, aims to prolong psoriasis recurrence by improving vascular endothelial barrier function. During the study, disease relapse (assessed via PASI scores) and safety indicators (e.g., adverse events, laboratory tests) will be regularly monitored. |
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| Placebo Comparator Group | Placebo Comparator | Participants in this group will receive matching placebo capsules orally after discontinuing secukinumab. The dosing regimen is 1 capsule twice daily for 120 consecutive days or until psoriasis relapse is confirmed. The placebo capsules are identical in appearance and packaging to the active sulodexide capsules but contain no active pharmaceutical ingredients. This group serves as a control to evaluate the efficacy of sulodexide in delaying psoriasis recurrence. Disease relapse (assessed via PASIscores) and safety indicators (e.g., adverse events, laboratory tests) will be monitored at the same intervals as the experimental group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulodexide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis lesion size and severity index score[PASI] | Psoriasis lesion size and severity index score | 1 year |
| Dermatological Quality of Life Index[DLQI] | Dermatological Quality of Life Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gang Wang | xjjing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| xjjing Hospital | Xi'an | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33812489 | Result | Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021 Apr 3;397(10281):1301-1315. doi: 10.1016/S0140-6736(20)32549-6. | |
| 32427307 | Result | Armstrong AW, Read C. Pathophysiology, Clinical Presentation, and Treatment of Psoriasis: A Review. JAMA. 2020 May 19;323(19):1945-1960. doi: 10.1001/jama.2020.4006. |
| Label | URL |
|---|---|
| PubMed is a free search engine maintained by the U.S. National Library of Medicine (NLM). It provides access to over 38 million citations from MEDLINE, life science journals, and online books, often linking to full - text articles on PubMed Central or pu | View source |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C007858 | glucuronyl glucosamine glycan sulfate |
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| Placebo | Drug | 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. |
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| 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. | 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. | 1 year |
| Adverse Events [AEs] | AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 | 1 year |
| 35601055 | Result | Tian D, Lai Y. The Relapse of Psoriasis: Mechanisms and Mysteries. JID Innov. 2022 Mar 9;2(3):100116. doi: 10.1016/j.xjidi.2022.100116. eCollection 2022 May. |
| 31595056 | Result | Chen L, Shen Z. Tissue-resident memory T cells and their biological characteristics in the recurrence of inflammatory skin disorders. Cell Mol Immunol. 2020 Jan;17(1):64-75. doi: 10.1038/s41423-019-0291-4. Epub 2019 Oct 8. |
| 32365242 | Result | Yelamos O, Alejo B, Ertekin SS, Villa-Crespo L, Zamora-Barquero S, Martinez N, Dominguez M, Iglesias P, Herrero A, Malvehy J, Puig S. Non-invasive clinical and microscopic evaluation of the response to treatment with clobetasol cream vs. calcipotriol/betamethasone dipropionate foam in mild to moderate plaque psoriasis: an investigator-initiated, phase IV, unicentric, open, randomized clinical trial. J Eur Acad Dermatol Venereol. 2021 Jan;35(1):143-149. doi: 10.1111/jdv.16559. Epub 2020 Jul 6. |
| 31899186 | Result | Zhu Z, Chen J, Lin Y, Zhang C, Li W, Qiao H, Fu M, Dang E, Wang G. Aryl Hydrocarbon Receptor in Cutaneous Vascular Endothelial Cells Restricts Psoriasis Development by Negatively Regulating Neutrophil Recruitment. J Invest Dermatol. 2020 Jun;140(6):1233-1243.e9. doi: 10.1016/j.jid.2019.11.022. Epub 2019 Dec 30. |
| 32888954 | Result | Chen J, Zhu Z, Li Q, Lin Y, Dang E, Meng H, Sha N, Bai H, Wang G, An S, Shao S. Neutrophils Enhance Cutaneous Vascular Dilation and Permeability to Aggravate Psoriasis by Releasing Matrix Metallopeptidase 9. J Invest Dermatol. 2021 Apr;141(4):787-799. doi: 10.1016/j.jid.2020.07.028. Epub 2020 Sep 2. |
| 33995668 | Result | Li Q, Zhu Z, Wang L, Lin Y, Fang H, Lei J, Cao T, Wang G, Dang E. Single-cell transcriptome profiling reveals vascular endothelial cell heterogeneity in human skin. Theranostics. 2021 Apr 19;11(13):6461-6476. doi: 10.7150/thno.54917. eCollection 2021. |
| 36917196 | Result | Li Q, Shao S, Zhu Z, Chen J, Hao J, Bai Y, Li B, Dang E, Wang G. An IGFBP7hi endothelial cell subset drives T cell extravasation in psoriasis via endothelial glycocalyx degradation. J Clin Invest. 2023 May 1;133(9):e160451. doi: 10.1172/JCI160451. |