Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

This study is not yet open for participant recruitment.

Verified by Postgraduate Institute of Medical Education and Research, November 2006

First Received: November 3, 2006 No Changes Posted

Sponsor:	Postgraduate Institute of Medical Education and Research
Information provided by:	Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:	NCT00395941

Purpose

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

Condition	Intervention	Phase
Psoriasis	Drug: Pioglitazone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:

Change in PASI score from baseline in the two groups

Secondary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395941

Contacts

Contact: Samir Malhotra, MD, DM

+91-172-2755243

samirmalhotra345@yahoo.com

Locations

India
PGIMER
Chandigarh, India, 160012

Sponsors and Collaborators

Postgraduate Institute of Medical Education and Research

Investigators

Study Chair:

Sunil Dogra, MD

PGIMER

More Information

No publications provided by Postgraduate Institute of Medical Education and Research

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	Pharma 6/699
Study First Received:	November 3, 2006
Last Updated:	November 3, 2006
ClinicalTrials.gov Identifier:	NCT00395941 History of Changes
Health Authority:	India : PGIMER

Additional relevant MeSH terms:

Hypoglycemic Agents
Pioglitazone
Skin Diseases
Psoriasis

Physiological Effects of Drugs
Skin Diseases, Papulosquamous
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009