Clinical trial NCT01714284: Efficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis
Official title: Multicenter Randomized Clinical Study Evaluating the Efficacy of Dietary Intervention and Weight Loss in Improving Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: psoriasis
Lead sponsor: Centro Studi Gised
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero-Universitaria di Modena
First posted: 2012-10-25
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Any change from baseline of PASI index
timeFrame: 20 weeks
Secondary outcomes:
measure: Percent change from baseline of PASI index equal to or greater than 50% (PASI50+)
timeFrame: 8 weeks, 16 weeks, 20 weeks
measure: Percent change from baseline of PASI index equal to 100% (PASI100)
timeFrame: 8 weeks, 16 weeks, 20 weeks
measure: Any change from baseline of PASI index
timeFrame: 8 weeks, 16 weeks, 20 weeks
measure: Any reduction from baseline of Body Mass Index (BMI)
timeFrame: 8 weeks, 16 weeks, 20 weeks
measure: Any reduction from baseline of waist circumference
timeFrame: 8 weeks, 16 weeks, 20 weeks
measure: Percent change from baseline of PASI index equal to or greater than 75% (PASI75+)
timeFrame: 8 weeks, 16 weeks, 20 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Department of Dermatology; Bellaria-Maggiore Hospital
state: Emilia Romagna
city: Bologna
country: Italy
facility: Department of Dermatology; S.Orsola-Malpighi General Hospital
state: Emilia Romagna
city: Cesena
country: Italy
facility: Dermatology Department; M. Bufalini Hospital
state: Emilia Romagna
city: Ferrara
country: Italy
facility: Department of Dermatology; S. Anna University Hospital
state: Emilia Romagna
city: Forlì
country: Italy
facility: Department of Dermatology; G.B.Morgagni-L.Pierantoni Hospital
state: Emilia Romagna
city: Modena
country: Italy
facility: Department of Dermatology; University General Hospital of Modena
state: Emilia Romagna
city: Parma
country: Italy
facility: Department of Dermatology; University General Hospital of Parma
state: Emilia Romagna
city: Piacenza
country: Italy
facility: Department of Dermatology; Hospital of Piacenza
state: Emilia Romagna
city: Ravenna
country: Italy
facility: Department of Dermatology; AUSL of Ravenna
state: Emilia Romagna
city: Reggio Emilia
country: Italy
facility: Department of Dermatology; S. Maria Nuova Hospital
state: Emilia Romagna
city: Rimini
country: Italy
facility: Department of Dermatology; Infermi Hospital
state: Emilia Romagna
Study officials:
affiliation: Centro Studi Gised
name: Luigi Naldi, MD
role: STUDY_DIRECTOR
affiliation: University General Hospital of Modena
name: Alberto Giannetti, MD
role: PRINCIPAL_INVESTIGATOR
References: