Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2006 by Postgraduate Institute of Medical Education and Research.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Postgraduate Institute of Medical Education and Research

ClinicalTrials.gov Identifier:

NCT00395941

First received: November 3, 2006

Last updated: NA

Last verified: November 2006

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 3, 2006

Last Updated Date

November 3, 2006

Start Date ^ICMJE

December 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change in PASI score from baseline in the two groups

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Proportion of subjects with an improvement of at least 75% in the psoriasis area-and-severity index (PASI) by week 12

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

Official Title ^ICMJE

Not Provided

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

Drug: Pioglitazone

Study Arm (s)

Not Provided

Publications *

Mittal R, Malhotra S, Pandhi P, Kaur I, Dogra S. Efficacy and safety of combination Acitretin and Pioglitazone therapy in patients with moderate to severe chronic plaque-type psoriasis: a randomized, double-blind, placebo-controlled clinical trial. Arch Dermatol. 2009 Apr;145(4):387-93.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact: Samir Malhotra, MD, DM

+91-172-2755243

samirmalhotra345@yahoo.com

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT00395941

Other Study ID Numbers ^ICMJE

Pharma 6/699

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Postgraduate Institute of Medical Education and Research

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Sunil Dogra, MD

PGIMER

Information Provided By

Postgraduate Institute of Medical Education and Research

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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