Psoriasis
Conditions
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.
Interventions
DRUGPioglitazone
DRUGAcitretin
Acitretin
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in PASI score from baseline in the two groups | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with an improvement of at least 75% in the psoriasis area-and-severity index (PASI) by week 12 | 12 weeks |
Countries
India
Outcome results
None listed