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Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Postgraduate Institute of Medical Education and Research
  More Information

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

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

ClinicalTrials.gov processed this record on September 19, 2017