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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.
Sponsor:
Information provided by:
Universita di Verona
ClinicalTrials.gov Identifier:
NCT00512187
First received: August 6, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted

August 6, 2007
August 6, 2007
November 2005
Not Provided
Primary end point PASI 75 response [ Time Frame: week 24 ]
Same as current
No Changes Posted
secondary end point was % of body weight reduction [ Time Frame: week 24 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Chronic Plaque Psoriasis
  • Obesity
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
Experimental: first group
patients who adhered to a low-calorie diet associated to sub-optimal cyclosporine dose (2.5 mg/Kg/day)for 24 weeks
Intervention: Other: low calorie diet
Gisondi P, Del Giglio M, Di Francesco V, Zamboni M, Girolomoni G. Weight loss improves the response of obese patients with moderate-to-severe chronic plaque psoriasis to low-dose cyclosporine therapy: a randomized, controlled, investigator-blinded clinical trial. Am J Clin Nutr. 2008 Nov;88(5):1242-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
August 2007
Not Provided

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00512187
GISONDI 1, no grants received at all
No
Not Provided
Universita di Verona
Not Provided
Principal Investigator: Giampiero Girolomoni University of Verona, Section of Dermatology and Venereology
Universita di Verona
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP