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
- Interventions
- Other: low calorie diet
- 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
- Arm && Interventions
Group Intervention Description first group low calorie diet patients who adhered to a low-calorie diet associated to sub-optimal cyclosporine dose (2.5 mg/Kg/day)for 24 weeks
- 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
Trial Locations
- Locations (1)
University of Verona
🇮🇹Verona, Italy