Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Acitretin; Drug: Pioglitazone

Study type: Interventional

Funder types: Other

Identifiers

NCT00395941

Pharma 6/699

Details and patient eligibility

About

Acitretin, when given in combiantion with pioglitazone might achieve better and/or more rapid control of moderate to severe chronic plaque type psoriasis.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Control

Active Comparator group

Description:

Acitretin

Treatment:

Drug: Acitretin

Experimental

Experimental group

Description:

Pioglitazone

Treatment:

Drug: Pioglitazone