Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis
- Registration Number
- NCT00395941
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Brief Summary
Acitretin, when given in combiantion with pioglitazone might achieve better and/or more rapid control of moderate to severe chronic plaque type psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Patients with chronic plaque type psoriasis having body surface area involvement of > 20%
- Patients of either sex
- Females who have completed their family and are tubectomized or are postmenopausal i.e. no menstrual bleeding over at least 1 year
- Age range 18-65 years
Exclusion Criteria
- Females of child bearing potential
- H/O hypersensitivity to acitretin
- Impaired hepatic function (serum bilirubin, AST, ALT and alkaline phosphatase >1.5 times the upper limit of normal)
- Impaired renal function (serum creatinine >1.5mg% in males and >1.4 mg% in females)
- Hyperlipidemia
- BMI >30 kg /m2
- H/O excessive alcohol use
- Diabetes mellitus
- Congestive heart failure
- Ischemic heart disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Pioglitazone Pioglitazone Control Acitretin Acitretin
- Primary Outcome Measures
Name Time Method Change in PASI score from baseline in the two groups 12 weeks
- Secondary Outcome Measures
Name Time Method Proportion of subjects with an improvement of at least 75% in the psoriasis area-and-severity index (PASI) by week 12 12 weeks
Trial Locations
- Locations (1)
PGIMER
🇮🇳Chandigarh, India