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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
  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 2

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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
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 Not yet recruiting
Chandigarh, India, 160012
Contact: Samir Malhotra, MD, DM     +91-172-2755243     samirmalhotra345@yahoo.com    
Sub-Investigator: Promila Pandhi, MD,DM            
Principal Investigator: Samir Malhotra, MD, DM            
Sub-Investigator: Inderjeet Kaur, md            
Sub-Investigator: Sunil Dogra, MD            
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 ClinicalTrials.gov Identifier (NCT Number):

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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Pioglitazone
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013