Efficacy and Safety of Acitretin Plus Pioglitazone in Pat... | NCT00395941

Studies
Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

NCT00395941

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Status

Completed

Last Update Posted

Mar 20, 2019Actual

Enrollment

40Actual

Phase

Phase 2

Conditions

Psoriasis

Interventions

Pioglitazone
Acitretin

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006Actual

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Nov 3, 2006

First Submission Date that Met QC Criteria

Nov 3, 2006

First Posted Date

Nov 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2019

Last Update Posted Date

Mar 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

SHotra, professor, Post Graduate Institute of Medical Education and Research, ChandigarhPrincipal Investigator

Lead Sponsor

Post Graduate Institute of Medical Education and Research, ChandigarhOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	Acitretin	Drug: Acitretin
Experimental	Experimental	Pioglitazone	Drug: Pioglitazone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pioglitazone	Drug		Experimental
Acitretin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in PASI score from baseline in the two groups		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Proportion of subjects with an improvement of at least 75% in the psoriasis area-and-severity index (PASI) by week 12		12 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sunil Dogra, MD	Post Graduate Institute of Medical Education and Research, Chandigarh	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PGIMER		Chandigarh		160012	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19380660	Derived	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.

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals