Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial
Phase 4
Completed
- Conditions
- Chronic Plaque PsoriasisObesity
- Registration Number
- NCT00512187
- Lead Sponsor
- Universita di Verona
- Brief Summary
The study hypothesis is to investigate whether a moderate weight loss (i.e. a weight reduction of at least 5%) could improve the response rate to a suboptimal dose of cyclosporine in patients with severe psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 18 years of age,active but clinically stable plaque psoriasis involving at least 10 percent of the body surface area and a psoriasis area and severity index (PASI) score ≥10 and a body mass index ≥30.
Exclusion Criteria
- Other type of psoriasis (guttate, erythrodermic and pustular psoriasis)
- Uncontrolled hypertension
- Severe congestive heart failure
- Renal and liver impairment
- Active or chronic infections, including HIV, HBV and HCV infections, latent tuberculosis
- Previous or active malignancies
- Pregnancy and lactations
- Previous treatment with cyclosporine
- Phototherapy or any systemic or topical therapy for psoriasis within the previous 4 weeks before enrolment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary end point PASI 75 response week 24
- Secondary Outcome Measures
Name Time Method secondary end point was % of body weight reduction week 24
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms link moderate weight loss to enhanced cyclosporine efficacy in severe chronic plaque psoriasis?
How does sub-optimal cyclosporine dosing in combination with low-calorie diets compare to standard psoriasis treatments in obese patients?
Are there specific biomarkers that predict improved psoriasis response to cyclosporine after moderate weight loss in obese individuals?
What are the potential adverse events associated with low-calorie diet interventions in obese psoriasis patients undergoing cyclosporine therapy?
How do combination approaches of weight management and immunosuppressants like cyclosporine influence the therapeutic landscape for severe chronic plaque psoriasis in obese populations?
Trial Locations
- Locations (1)
University of Verona
🇮🇹Verona, Italy
University of Verona🇮🇹Verona, Italy