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CompletedNCT00395941Updated Mar 20, 2019

Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

A Phase 2 interventional study of Pioglitazone and Acitretin in Psoriasis, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-03-20.

Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Acitretin, when given in combiantion with pioglitazone might achieve better and/or more rapid control of moderate to severe chronic plaque type psoriasis.

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 40 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

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Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Control

    Acitretin

    Drug: Acitretin

  • Experimental
    Experimental

    Pioglitazone

    Drug: Pioglitazone

Interventions

  • DrugPioglitazone
  • DrugAcitretin

    Acitretin

06

What researchers measure

Primary outcomes

  1. Change in PASI score from baseline in the two groups

    Time frame: 12 weeks

Secondary outcomes

  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

07

Study locations

1 site
  • PGIMER
    Chandigarh, 160012, India
08

References and documents

Publications

  • 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. PubMed 19380660 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00395941
Lead sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Responsible party
SHotra (professor, Post Graduate Institute of Medical Education and Research, Chandigarh) — Principal investigator
First posted
Nov 6, 2006
Start date
Dec 2006
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Mar 20, 2019

Study contacts

Sunil Dogra, MD
study chair · Post Graduate Institute of Medical Education and Research, Chandigarh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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