NCT00110682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

April 24, 2008

Status Verified

April 1, 2008

Enrollment Period

1.5 years

First QC Date

May 12, 2005

Last Update Submit

April 21, 2008

Conditions

KeratosisActinic Keratosis

Keywords

Actinic KeratosisCryotherapyImiquimod

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate and time to recurrence of lesions

Secondary Outcomes (3)

  • Time to reach treatment success

  • Percentage of patients who clear

  • Patient improvement assessment

Interventions

Imiquimod used as an adjunct to cryotherapyDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

DermResearch @ 888 Inc

Vancouver, British Columbia, V4C 6X4, Canada

Location

Windsor Clinical Research

Windsor, Ontario, Canada

Location

Centre de Recherche Dermatologique, CRDQ

Sainte-Foy, Quebec, G1V 4X7, Canada

Location

MeSH Terms

Conditions

KeratosisKeratosis, Actinic

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPrecancerous ConditionsNeoplasms

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 12, 2005

First Posted

May 13, 2005

Study Start

April 1, 2005

Primary Completion

October 1, 2006

Study Completion

December 1, 2006

Last Updated

April 24, 2008

Record last verified: 2008-04

Locations

CA(3)