- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07382388
A Real-World Study on the Impact of Weight Loss on Treatment Efficacy in Overweight/Obese Patients With Plaque Psoriasis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pregnant or lactating women.
- Individuals deemed by the investigator to be unsuitable for participation in this study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Weight Loss Group
receiving standard psoriasis care plus a personalized weight management program
|
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.
|
|
Control Group
receiving standard psoriasis care only
|
Receive standardized treatment for their psoriasis based on disease severity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of PASI<3 at Week 24
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of PASI<3 at Week 12
Time Frame: Week 12
|
Proportion of patients undergoing weight loss treatment who achieve a PASI score below 3 at Week 12.
|
Week 12
|
|
Changes of BMI
Time Frame: Week 12 and Week 24
|
Changes from baseline in Body Mass Index (BMI) at Week 12 and Week 24 in patients undergoing weight loss treatment.
|
Week 12 and Week 24
|
|
Proportion of PGA 0/1 (Physician's Global Assessment)
Time Frame: Week 12 and Week 24
|
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
Time Frame: Week 12 and Week 24
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M20260001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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