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.

First Received: August 6, 2007 No Changes Posted

Sponsor:	Universita di Verona
Information provided by:	Universita di Verona
ClinicalTrials.gov Identifier:	NCT00512187

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diets Obesity Psoriasis Weight Control

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

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
first group: Experimental 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

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 National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	GISONDI 1, no grants received at all
Study First Received:	August 6, 2007
Last Updated:	August 6, 2007
ClinicalTrials.gov Identifier:	NCT00512187 History of Changes
Health Authority:	Italy: Ethics Committee

Additional relevant MeSH terms:

Obesity
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Physiological Effects of Drugs
Overweight
Enzyme Inhibitors
Immunosuppressive Agents
Cyclosporins

Pharmacologic Actions
Body Weight
Signs and Symptoms
Psoriasis
Weight Loss
Body Weight Changes
Nutrition Disorders
Overnutrition
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 30, 2009