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Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00395941
Recruitment Status : Unknown
Verified November 2006 by Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Not yet recruiting
First Posted : November 6, 2006
Last Update Posted : November 6, 2006
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Pioglitazone Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources




Primary Outcome Measures :
  1. Change in PASI score from baseline in the two groups

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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 6, 2006    Key Record Dates
Last Update Posted: November 6, 2006
Last Verified: November 2006

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