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Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Pioglitazone
Acitretin
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PGIMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Acitretin

Pioglitazone

Outcomes

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

Full Information

First Posted
November 3, 2006
Last Updated
March 19, 2019
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT00395941
Brief Title
Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 2006 (Actual)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Acitretin
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Pioglitazone
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Type
Drug
Intervention Name(s)
Acitretin
Intervention Description
Acitretin
Primary Outcome Measure Information:
Title
Change in PASI score from baseline in the two groups
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Dogra, MD
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Study Chair
Facility Information:
Facility Name
PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
19380660
Citation
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. doi: 10.1001/archdermatol.2009.5.
Results Reference
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Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

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