Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

Psoriasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395941
• Other study ID #: Pharma 6/699
• Status: Completed
• Phase: Phase 2
• Start date: December 2006
• Est. completion date: December 2008

Study information

• Verified date: March 2019
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Pioglitazone

• Acitretin
Acitretin

Locations

Country	Name	City	State
India	PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PASI score from baseline in the two groups		12 weeks
Secondary	Proportion of subjects with an improvement of at least 75% in the psoriasis area-and-severity index (PASI) by week 12		12 weeks