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OpenTrials
Completed

NCT Number: NCT00512187

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

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.

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Key information

Conditions

Chronic Plaque Psoriasis Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Verona

Verona, 37126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Primary end point PASI 75 response

    Time frame: week 24

Secondary outcomes

  1. secondary end point was % of body weight reduction

    Time frame: week 24

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Important dates

Study start
2005
Study completion
2007
First posted
Aug 7, 2007
Registry last updated
Aug 7, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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