Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

NCT ID: NCT00395941

Last Updated: 2019-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Acitretin

Group Type ACTIVE_COMPARATOR

Acitretin

Intervention Type DRUG

Acitretin

Experimental

Pioglitazone

Group Type EXPERIMENTAL

Pioglitazone

Intervention Type DRUG

Interventions

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Pioglitazone

Intervention Type DRUG

Acitretin

Acitretin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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SHotra

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sunil Dogra, MD

Role: STUDY_CHAIR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

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PGIMER

Chandigarh, , India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 19380660 (View on PubMed)

Other Identifiers

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Pharma 6/699

Identifier Type: -

Identifier Source: org_study_id

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