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 - Tabular View

Tracking Information

First Received Date ^ICMJE

August 6, 2007

Last Updated Date

August 6, 2007

Start Date ^ICMJE

November 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Primary end point PASI 75 response [ Time Frame: week 24 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

secondary end point was % of body weight reduction [ Time Frame: week 24 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Plaque Psoriasis
Obesity

Intervention ^ICMJE

Other: low calorie diet

Study Arms / Comparison Groups

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

Publications *

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00512187

Responsible Party

Study ID Numbers ^ICMJE

GISONDI 1, no grants received at all

Study Sponsor ^ICMJE

Universita di Verona

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Giampiero Girolomoni

University of Verona, Section of Dermatology and Venereology

Information Provided By

Universita di Verona

Verification Date

August 2007

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