A Real-World Study on the Impact of Weight Loss on Treatment Efficacy in Overweight/Obese Patients With Plaque Psoriasis

Обзор

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.

Вмешательства

• Комбинированный продукт Weight loss and psoriasis treatment
  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.
• Комбинированный продукт psoriasis treatment
  Receive standardized treatment for their psoriasis based on disease severity.

Первичные конечные точки

• Proportion of PASI<3 at Week 24 [Срок оценки: Week 24]

Вторичные конечные точки (4)

• Proportion of PASI<3 at Week 12 [Срок оценки: Week 12]
• Changes of BMI [Срок оценки: Week 12 and Week 24]
• Proportion of PGA 0/1 (Physician's Global Assessment) [Срок оценки: Week 12 and Week 24]
• Proportion of DLQI<6 [Срок оценки: Week 12 and Week 24]

Критерии участия

Критерии включения

• Age ≥ 18 years, regardless of gender.
• Having signed the informed consent form.
• Clinical diagnosis of plaque psoriasis.
• Body Mass Index (BMI) categorized as overweight or obese.
• For female patients: No plans for pregnancy or oocyte donation during the study period and voluntary use of highly effective physical contraception.

Критерии исключения

• Pregnant or lactating women.
• Individuals deemed by the investigator to be unsuitable for participation in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07382388 · M20260001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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