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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512187
• Other study ID #: GISONDI 1
• Secondary ID: no grants receiv
• Status: Completed
• Phase: Phase 4
• First received: August 6, 2007
• Last updated: August 6, 2007
• Start date: November 2005
• Est. completion date: August 2007

Study information

• Verified date: August 2007
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Obesity
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Italy	University of Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary end point PASI 75 response		week 24
Secondary	secondary end point was % of body weight reduction		week 24