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

NCT ID: NCT00512187

Last Updated: 2007-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2007-08-31

Brief 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.

Conditions

Chronic Plaque Psoriasis; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

first group

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

Group Type: EXPERIMENTAL

low calorie diet

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Principal Investigators

Giampiero Girolomoni

Role: PRINCIPAL_INVESTIGATOR

University of Verona, Section of Dermatology and Venereology

Locations

University of Verona

Verona, , Italy

Countries

Italy

References

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. doi: 10.3945/ajcn.2008.26427.

Reference Type: DERIVED

PMID: 18996858 (View on PubMed)

Other Identifiers

no grants received at all

Identifier Type: -

Identifier Source: secondary_id

GISONDI 1

Identifier Type: -

Identifier Source: org_study_id