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The goal of this investigator-initiated, real-world, observational study is to investigate the impact of weight loss on treatment efficacy in overweight or obese Chinese patients with moderate-to-severe plaque psoriasis.
The main question it aims to answer is:
Does a structured weight loss intervention (including dietary management, exercise, and/or pharmacotherapy) improve the clinical response to psoriasis therapy in this population, as measured by the proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score below 3 at Week 24?
Researchers will compare the Weight Loss Intervention Group (receiving standard psoriasis care plus a personalized weight management program) to the Control Group (receiving standard psoriasis care only) to see if the addition of weight loss strategies leads to superior improvements in psoriasis severity, metabolic parameters, and quality of life.
Participants will:
Receive standardized treatment for their psoriasis based on disease severity.
Be allocated (based on patient preference and clinical judgment) to either the intervention or control group.
In the intervention group, receive and follow a personalized weight management plan, which may include dietary counseling, a tailored exercise regimen, and/or Glucagon-Like Peptide-1(GLP-1) receptor agonist therapy (e.g., Semaglutide, Tirzepatide) if indicated.
Undergo scheduled assessments at baseline, Week 12, and Week 24, including:
Clinical evaluations (PASI, Physician's Global Assessment, body surface area).
Anthropometric measurements (weight, BMI, waist/hip circumference).
Quality of life assessment (Dermatology Life Quality Index).
Safety monitoring for adverse events. To investigate the impact of weight loss on treatment efficacy among overweight/obese Chinese patients with plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Loss Group | receiving standard psoriasis care plus a personalized weight management program |
| |
| Control Group | receiving standard psoriasis care only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss and psoriasis treatment | Combination Product | In the weight loss group, receive standardized treatment for their psoriasis based on disease severity and follow a personalized weight management plan, which may include dietary counseling, a tailored exercise regimen, and/or GLP-1 receptor agonist therapy (e.g., Semaglutide, Tirzepatide) if indicated. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of PASI<3 at Week 24 | Proportion of patients undergoing weight loss treatment who achieve a Psoriasis Area and Severity Index (PASI) score below 3 at Week 24. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of PASI<3 at Week 12 | Proportion of patients undergoing weight loss treatment who achieve a PASI score below 3 at Week 12. | Week 12 |
| Changes of BMI | Changes from baseline in Body Mass Index (BMI) at Week 12 and Week 24 in patients undergoing weight loss treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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Clinical diagnosis of plaque psoriasis and Body Mass Index (BMI) categorized as overweight or obese.
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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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| psoriasis treatment | Combination Product | Receive standardized treatment for their psoriasis based on disease severity. |
|
| Week 12 and Week 24 |
| Proportion of PGA 0/1 (Physician's Global Assessment) | Proportion of patients undergoing weight loss treatment who achieve a Physician's Global Assessment (PGA) score of 0 or 1 at Week 12 and Week 24. | Week 12 and Week 24 |
| Proportion of DLQI<6 | Proportion of patients undergoing weight loss treatment who achieve a Dermatology Life Quality Index (DLQI) score below 6 at Week 12 and Week 24 | Week 12 and Week 24 |