Back to resultsModerate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial
Primary Purpose
Chronic Plaque Psoriasis, Obesity
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
low calorie diet
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Plaque Psoriasis
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.
Sites / Locations
- University of Verona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
first group
Arm Description
patients who adhered to a low-calorie diet associated to sub-optimal cyclosporine dose (2.5 mg/Kg/day)for 24 weeks
Outcomes
Primary Outcome Measures
Primary end point PASI 75 response
Secondary Outcome Measures
secondary end point was % of body weight reduction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00512187
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universita di Verona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
first group
Arm Type
Experimental
Arm Description
patients who adhered to a low-calorie diet associated to sub-optimal cyclosporine dose (2.5 mg/Kg/day)for 24 weeks
Intervention Type
Other
Intervention Name(s)
low calorie diet
Intervention Description
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 Outcome Measure Information:
Title
Primary end point PASI 75 response
Time Frame
week 24
Secondary Outcome Measure Information:
Title
secondary end point was % of body weight reduction
Time Frame
week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giampiero Girolomoni
Organizational Affiliation
University of Verona, Section of Dermatology and Venereology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
18996858
Citation
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.
Results Reference
derived
Learn more about this trial
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
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