Study of Imiquimod 5% Cream in Addition to Cryotherapy in... | NCT00110682

Studies
Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses

NCT00110682

Sponsor

Derm Research @ 888 Inc.

Status

Completed

Last Update Posted

Apr 24, 2008Estimated

Enrollment

Phase

Phase 4

Conditions

Keratosis
Actinic Keratosis

Interventions

Imiquimod used as an adjunct to cryotherapy

Countries

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

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

Apr 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

Apr 2005

Primary Completion Date

Oct 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

May 12, 2005

First Submission Date that Met QC Criteria

May 12, 2005

First Posted Date

May 13, 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

Apr 21, 2008

Last Update Posted Date

Apr 24, 2008Estimated

Name	Class
3M	INDUSTRY

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

Study Aims:

To compare the long-term efficacy and safety of imiquimod versus vehicle used as an adjunct to cryotherapy.
To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups.

Hypothesis: The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses (AK) compared to the vehicle arm.

Detailed Description

Evaluation of: (i) topical imiquimod 5% cream or (ii) vehicle cream used two times weekly for eight weeks starting two weeks post cryotherapy.

Study Aims:

To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups.
To assess and compare the efficacy of the 2 different treatment groups.
To assess and compare the safety of the 2 different treatment groups.

Study Design: 6 visits over 62 weeks

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

Name	Type	Description	Arm Group Labels	Other Names
Imiquimod used as an adjunct to cryotherapy	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence rate and time to recurrence of lesions

Secondary Outcomes

Measure	Description	Time Frame
Time to reach treatment success
Percentage of patients who clear
Patient improvement assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of actinic keratosis with 4 or more discreet lesions on the face or balding scalp. Lesions must be within a treatment area not exceeding 50 cm2 (combined total must not exceed 50 cm2)
Women of childbearing potential using appropriate contraceptive methods

Exclusion Criteria:

Previous treatments with imiquimod for AK in the prescribed area within the past 5 months or cryosurgery in the same area within the past 4 weeks.
Patients unwilling to stay out of the sun or wear protective clothing or to use sunscreen with a minimum of SPF 15 during the study.
Basal or squamous cell carcinomas in the prescribed treatment area in the past 2 years.

Accepts Healthy Volunteers

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yves Poulin, MD FRCPC	Centre de Recherche Dermatologique du Quebec Metropolitaine	Principal Investigator
Jerry KL Tan, MD FDRPC	U. of Western Ontario, Windsor Ontario	Principal Investigator
Richard Thomas, MD FRCPC	Derm Research @ 888 Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DermResearch @ 888 Inc		Vancouver	British Columbia	V4C 6X4	Canada
Windsor Clinical Research

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