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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Universita di Verona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00512187     History of Changes
Other Study ID Numbers: GISONDI 1, no grants received at all
Study First Received: August 6, 2007
Last Updated: August 6, 2007
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Psoriasis
Weight Loss
Skin Diseases, Papulosquamous
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 30, 2014