Efficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis

Not Applicable

Completed

• Conditions: Psoriasis
• Interventions: Behavioral: Diet and Exercise; Behavioral: Informative

• Registration Number: NCT01714284
• Lead Sponsor: Centro Studi Gised

Brief Summary

This is a multicenter randomized controlled clinical trial evaluating the impact of a structured non pharmacological intervention consisting in intensive weight reduction (qualitative and quantitative changes in diet associated with physical exercise) compared to an intervention based on a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-25
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-21
• Last Update Posted: 2013-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

Inclusion Criteria

• Diagnosis of chronic plaque psoriasis
• BMI > 25 Kg/m²
• Patients under systemic treatments for psoriasis or candidates for such treatments

Exclusion Criteria

• Diagnosis of other type of psoriasis or psoriatic arthritis
• Patients under local treatments or candidates for such treatments
• Patients expected to have poor compliance at follow-up evaluation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet and Exercise	Diet and Exercise	-
Informative	Informative	-

Primary Outcome Measures

Name	Time	Method
Any change from baseline of PASI index	20 weeks

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline of PASI index equal to or greater than 50% (PASI50+)	8 weeks, 16 weeks, 20 weeks
Percent change from baseline of PASI index equal to 100% (PASI100)	8 weeks, 16 weeks, 20 weeks
Any change from baseline of PASI index	8 weeks, 16 weeks, 20 weeks
Any reduction from baseline of Body Mass Index (BMI)	8 weeks, 16 weeks, 20 weeks
Any reduction from baseline of waist circumference	8 weeks, 16 weeks, 20 weeks
Percent change from baseline of PASI index equal to or greater than 75% (PASI75+)	8 weeks, 16 weeks, 20 weeks

Trial Locations

Locations (11)

Department of Dermatology; AUSL of Ravenna; 🇮🇹 Ravenna, Emilia Romagna, Italy

Department of Dermatology; Infermi Hospital; 🇮🇹 Rimini, Emilia Romagna, Italy

Department of Dermatology; S. Anna University Hospital; 🇮🇹 Ferrara, Emilia Romagna, Italy

Department of Dermatology; S.Orsola-Malpighi General Hospital; 🇮🇹 Bologna, Emilia Romagna, Italy

Department of Dermatology; Bellaria-Maggiore Hospital; 🇮🇹 Bologna, Emilia Romagna, Italy

Department of Dermatology; G.B.Morgagni-L.Pierantoni Hospital; 🇮🇹 Forlì, Emilia Romagna, Italy

Dermatology Department; M. Bufalini Hospital; 🇮🇹 Cesena, Emilia Romagna, Italy

Department of Dermatology; University General Hospital of Modena; 🇮🇹 Modena, Emilia Romagna, Italy

Department of Dermatology; Hospital of Piacenza; 🇮🇹 Piacenza, Emilia Romagna, Italy

Department of Dermatology; University General Hospital of Parma; 🇮🇹 Parma, Emilia Romagna, Italy

Department of Dermatology; S. Maria Nuova Hospital; 🇮🇹 Reggio Emilia, Emilia Romagna, Italy