Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2006
CompletedFirst Posted
Study publicly available on registry
November 6, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedMarch 20, 2019
March 1, 2019
2 years
November 3, 2006
March 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in PASI score from baseline in the two groups
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
12 weeks
Study Arms (2)
Control
ACTIVE COMPARATORAcitretin
Experimental
EXPERIMENTALPioglitazone
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PGIMER
Chandigarh, 160012, India
Related Publications (1)
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.
PMID: 19380660DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sunil Dogra, MD
Post Graduate Institute of Medical Education and Research, Chandigarh
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
November 3, 2006
First Posted
November 6, 2006
Study Start
December 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
March 20, 2019
Record last verified: 2019-03