Dose Ranging Study to Assess the Efficacy and Safety of A... | NCT01039142

Studies
Dose Ranging Study to Assess the Efficacy and Safety of Acitretin in Severe Plaque Type Psoriasis

NCT01039142

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Status

Completed

Last Update Posted

Dec 24, 2009Estimated

Enrollment

61Actual

Phase

Phase 4

Conditions

Psoriasis

Interventions

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

Feb 2008

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

Mar 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Dec 23, 2009

First Submission Date that Met QC Criteria

Dec 23, 2009

First Posted Date

Dec 24, 2009Estimated

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

Dec 23, 2009

Last Update Posted Date

Dec 24, 2009Estimated

Description Module

Brief Summary

In this study, the investigators will intend to compare the efficacy and safety of various doses of acitretin in a randomized double blind manner in patients with severe plaque-type psoriasis, by i) studying the change PASI score from baseline as a measure of efficacy ii) determining the frequency of side effects at various doses. Sixty patients will be recruited from Psoriasis Clinic of Department of Dermatology, Venerology and Leprology, PGIMER. Patients will be randomly assigned to one of the three groups: Group A, consisting of 20 patients, will be administered acitretin 25 mg/ day ,Group B, consisting of 20 patients, will be administered acitretin 35 mg/day and GROUP C consisting of 20 patients, will be administered acitretin 50 mg/day This therapy will be continued until PSORIASIS AREA AND SEVERITY INDEX (PASI) scores are reduced to < 25% of the original scores or 12 weeks, whichever comes earlier. It is expected that acitretin at higher doses will be more efficacious . As the exact etiopathogenesis of psoriasis is not fully known, it is difficult to provide a definite cure to all patients, though the disease activity can be controlled to a great extent with various treatment modalities. However the dosage of acitretin be adjusted according to response of the patients and tolerability of side effects.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
25 mg acitretin	Active Comparator	capsule acitretin 25 mg/day will be administered to each patient for a period of 12 weeks	Drug: Acitretin
35 mg acitretin	Active Comparator	capsule acitretin 35 mg/day will be administered to each patient for a period of 12 weeks	Drug: Acitretin
50 mg acitretin	Active Comparator	capsule acitretin 50 mg/day will be administered to each patient for a period of 12 weeks	Drug: Acitretin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acitretin	Drug	capsule acitretin in dose of 25 mg, 35 mg or 50 mg/ day for 12 weeks or reduction in PASI score by 75% whichever is earlier	25 mg acitretin 35 mg acitretin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Psoriasis area severity index from baseline to 12 weeks after acitretin therapy		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Frequency of adverse effects at 3 different doses of acitretin		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with plaque-type psoriasis having <90%of body surface area involvement, whose disease activity had been stable for the last 1month.
Age range 18-65 years of either sex
Females who are postmenopausal or tubectomised or have completed their family and are willing to maintain contraception 1 month before, during and 2 years after completion of treatment and negative pregnancy tests within 2 months of starting of treatment.
Compliance for scheduled visit.

Exclusion Criteria:

Patients with severe hepatic, renal or other systemic disorders (serum bilirubin,AST,ALT and alkaline phosphatase>1.5 times upper limit of normal;serum creatinine >1.5 mg% in males and >1.4mg% in females)
Pregnant or lactating women,contemplating pregnancy in next 2 -3 years
Alcoholic
Metabolic disorders such as hyperlipidemia
Obese/BMI≥ 30 kg/m2
Ischemic heart diseases,neuropsychiatric illness

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
Post Graduate institute Of Medical Education and Research		Chandigarh	Chandigarh	160012	India

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017255	Acitretin

Ancestor Terms

ID	Term
D012176	Retinoids
D002338	Carotenoids
D011090	Polyenes
D000475	Alkenes
D006839

Browse Leaves

Not provided

Browse Branches

Not provided