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
NCT00512187 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2007-08-07
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.
Conditions
- Chronic Plaque Psoriasis
- Obesity
Interventions
- OTHER
-
low calorie diet
Low calorie diet was designed to achieve a loss of 5-10% of initial weight. All enrolled patients received a balanced diet scheme, based on a caloric intake reduction related to BMI and sex (range 1200-1500 Kcal/day for women, 1300-1600 Kcal/day for men). Calorie intake consisted approximately of 60% carbohydrates, 25% fat, 15% protein
Sponsors & Collaborators
-
Universita di Verona
lead OTHER
Principal Investigators
-
Giampiero Girolomoni · University of Verona, Section of Dermatology and Venereology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-11-30
- Completion
- 2007-08-31
Countries
- Italy
Study Locations
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