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| Sponsor: | Universita di Verona |
|---|---|
| Information provided by: | Universita di Verona |
| ClinicalTrials.gov Identifier: | NCT00512187 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Plaque Psoriasis Obesity |
Other: low calorie diet |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Study Start Date: | November 2005 |
| Study Completion Date: | August 2007 |
| Arms | Assigned Interventions |
|---|---|
|
first group: Experimental
patients who adhered to a low-calorie diet associated to sub-optimal cyclosporine dose (2.5 mg/Kg/day)for 24 weeks
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| University of Verona | |
| Verona, Italy, 37126 | |
| Principal Investigator: | Giampiero Girolomoni | University of Verona, Section of Dermatology and Venereology |
More Information
| Study ID Numbers: | GISONDI 1, no grants received at all |
| Study First Received: | August 6, 2007 |
| Last Updated: | August 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00512187 History of Changes |
| Health Authority: | Italy: Ethics Committee |
|
Obesity Immunologic Factors Molecular Mechanisms of Pharmacological Action Skin Diseases Physiological Effects of Drugs Overweight Enzyme Inhibitors Immunosuppressive Agents Cyclosporins |
Pharmacologic Actions Body Weight Signs and Symptoms Psoriasis Weight Loss Body Weight Changes Nutrition Disorders Overnutrition Skin Diseases, Papulosquamous |