Working… Menu

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. Identifier: NCT00395941
Recruitment Status : Completed
First Posted : November 6, 2006
Last Update Posted : March 20, 2019
Information provided by (Responsible Party):
SHotra, 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 Drug: Acitretin Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : December 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: Control
Drug: Acitretin

Experimental: Experimental
Drug: Pioglitazone

Primary Outcome Measures :
  1. Change in PASI score from baseline in the two groups [ Time Frame: 12 weeks ]

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 [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00395941

Layout table for location information
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Layout table for investigator information
Study Chair: Sunil Dogra, MD Postgraduate Institute of Medical Education and Research

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: SHotra, professor, Postgraduate Institute of Medical Education and Research Identifier: NCT00395941     History of Changes
Other Study ID Numbers: Pharma 6/699
First Posted: November 6, 2006    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Diseases, Papulosquamous
Skin Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Keratolytic Agents
Dermatologic Agents