A Study to Assess the Long-Term Safety of Tacrolimus Crea... | NCT00293917 | Trialant

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A Study to Assess the Long-Term Safety of Tacrolimus Crea... | NCT00293917 | Trialant

Studies
A Study to Assess the Long-Term Safety of Tacrolimus Cream in the Treatment of Psoriasis

NCT00293917

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Feb 13, 2008Estimated

Enrollment

658Actual

Phase

Phase 3

Conditions

Psoriasis

Interventions

Tacrolimus Cream

Countries

United States
Canada

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

NCT00293917

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

04-0-207

Secondary IDs

Not provided

Brief Title

A Study to Assess the Long-Term Safety of Tacrolimus Cream in the Treatment of Psoriasis

Official Title

A Phase 3, Long-Term, Open Label Study to Evaluate the Safety of Twice Daily Tacrolimus Cream-B 0.1% in the Treatment of Psoriasis

Acronym

Not provided

Organization

Astellas Pharma IncINDUSTRY

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

No

Start Date

Jan 2006

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Feb 16, 2006

First Submission Date that Met QC Criteria

Feb 16, 2006

First Posted Date

Feb 20, 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

Feb 11, 2008

Last Update Posted Date

Feb 13, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Astellas Pharma IncINDUSTRY

Collaborators

Name	Class
Astellas Pharma US, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

No

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

A study to assess the long-term safety of tacrolimus cream in the treatment of psoriasis

Detailed Description

A long-term, open label, non-comparative, multi-center study to evaluate the safety of tacrolimus cream-B 0.1% in treating the signs and symptoms of psoriasis.

Conditions Module

Conditions

Psoriasis

Keywords

Treatment Outcome
Tacrolimus
Safety
Psoriasis

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

658Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus Cream	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety		12 months

Secondary Outcomes

Measure	Description	Time Frame
Efficacy		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of plaque psoriasis

Exclusion Criteria:

Skin disorder other than plaque psoriasis in the areas to be treated.
Disease on only scalp

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
M Rico, MD	Astellas Pharma US, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	30322	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Non-Randomized

Intervention Model

Single Group Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided

Fresno

California

93710

United States

Santa Monica

California

90404

United States

Vista

California

92083

United States

Jacksonville

Florida

32204

United States

Miami

Florida

United States

Atlanta

Georgia

30322

United States

Newnan

Georgia

30263

United States

Boise

Idaho

83704

United States

Chicago

Illinois

60614

United States

Chicago

Illinois

United States

Louisville

Kentucky

40202

United States

New Orleans

Louisiana

70112

United States

Boston

Massachusetts

02118

United States

Detroit

Michigan

48202

United States

Minneapolis

Minnesota

55455

United States

Lincoln

Nebraska

68502

United States

Reno

Nevada

89511

United States

Lebanon

New Hampshire

03756

United States

East Windsor

New Jersey

08520

United States

East Setauket

New York

11733

United States

New York

New York

10016

United States

New York

New York

10025

United States

Hershey

Pennsylvania

17033

United States

Simpsonville

South Carolina

29681

United States

Goodlettsville

Tennessee

37072

United States

Arlington

Texas

76011

United States

Houston

Texas

77056

United States

Bellingham

Washington

98225

United States

Kenatchee

Washington

98801

United States

Spokane

Washington

99202

United States

Winnipeg

Manitoba

R3C 1R4

Canada

St. John's

Newfoundland and Labrador

A1B 3E1

Canada

Halifax

Nova Scotia

B3H 1Z4

Canada

Hamilton

Ontario

L8N 1V6

Canada

Markham

Ontario

L3P 1AB

Canada

Windsor

Ontario

N8W 5L7

Canada

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