CompletedInterventionalPhase 2Updated Dec 21, 2017
Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis | NCT00395941 | Trialant
CompletedInterventionalPhase 2Updated Mar 20, 2019
Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis
ClinicalTrials.gov ID
NCT00395941
Lead Sponsor
Post Graduate Institute of Medical Education and Research, ChandigarhOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
40Actual
Last Update Posted
Mar 20, 2019Actual
Start Date
Dec 2006Actual
Primary Completion Date
Dec 2008Actual
Completion Date
Dec 2008Actual
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.
Psoriasis
Pioglitazone
Acitretin
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
No central contacts
There are no central contacts for this study.
PGIMER
Chandigarh, 160012, India
Lead Sponsor
Post Graduate Institute of Medical Education and Research, ChandigarhOTHER