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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

This study has been completed.

Sponsored by: 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

MedlinePlus related topics:   Obesity    Psoriasis    Weight Control   

ChemIDplus related topics:   Cyclosporine    Cyclosporin   

U.S. FDA Resources

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

Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Primary end point PASI 75 response [ Time Frame: week 24 ]

Secondary Outcome Measures:
  • secondary end point was % of body weight reduction [ Time Frame: week 24 ]

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

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512187

Locations
Italy
University of Verona    
      Verona, Italy, 37126

Sponsors and Collaborators
Universita di Verona

Investigators
Principal Investigator:     Giampiero Girolomoni     University of Verona, Section of Dermatology and Venereology    
  More Information


Study ID Numbers:   GISONDI 1, no grants received at all
First Received:   August 6, 2007
Last Updated:   August 6, 2007
ClinicalTrials.gov Identifier:   NCT00512187
Health Authority:   Italy: Ethics Committee

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Cyclosporine
Skin Diseases
Psoriasis
Weight Loss
Nutrition Disorders
Overweight
Overnutrition
Cyclosporins
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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