1-Year Follow up to the 1473-IMIQ Study | NCT00114023

Studies
1-Year Follow up to the 1473-IMIQ Study

NCT00114023

Sponsor

Graceway Pharmaceuticals, LLC

Status

Completed

Last Update Posted

Feb 19, 2007Estimated

Enrollment

Phase

Not provided

Conditions

Keratosis

Interventions

Imiquimod 5% cream

Countries

United States

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

Oct 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 13, 2005

First Submission Date that Met QC Criteria

Jun 13, 2005

First Posted Date

Jun 14, 2005Estimated

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 16, 2007

Last Update Posted Date

Feb 19, 2007Estimated

Description Module

Brief Summary

This is a 1-year follow-up study to evaluate the long-term effects in subjects who completely cleared their actinic keratosis (AK) lesions in the 1473-IMIQ study. The 1473-IMIQ study evaluated the safety and effectiveness of imiquimod 5% cream compared to a placebo cream for the treatment of AK.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Imiquimod 5% cream	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject had to participate in the 1473-IMIQ Study AND have had 100% clearance of AK lesions

Exclusion Criteria:

Did not use any topical preparations in the previous treatment area within 24-hours of the scheduled visit.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Little Rock	Arkansas	72205	United States

Condition Browse Module

MeSH Terms

ID	Term
D007642	Keratosis
D055623	Keratosis, Actinic

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D011230	Precancerous Conditions
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077271	Imiquimod

Ancestor Terms

ID	Term
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided