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

NCT00512187 | Completed Phase 4

• 2 other identifiers: GISONDI 1no grants received at all
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Primary end point PASI 75 response

  week 24

Secondary Outcomes (1)

• secondary end point was % of body weight reduction

  week 24

Study Arms (1)

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

Interventions

low calorie diet 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

first group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

University of Verona

Verona, 37126, Italy

Location

Related Publications (1)

• 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.

  PMID: 18996858 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Giampiero Girolomoni

  University of Verona, Section of Dermatology and Venereology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 7, 2007
• Study Start: November 1, 2005
• Study Completion: August 1, 2007
• Last Updated: August 7, 2007

Record last verified: 2007-08

Locations

IT (1)