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

University of Verona

Status and phase: Completed; Phase 4

Conditions: Chronic Plaque Psoriasis; Obesity

Treatments: Other: low calorie diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00512187

GISONDI 1

no grants received at all

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 1 patient group

first group

Experimental group

Description:

patients who adhered to a low-calorie diet associated to sub-optimal cyclosporine dose (2.5 mg/Kg/day)for 24 weeks

Treatment:

Other: low calorie diet