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

Primary Purpose

Keratosis, Actinic Keratosis

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Imiquimod used as an adjunct to cryotherapy
Sponsored by
Derm Research @ 888 Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratosis focused on measuring Actinic Keratosis, Cryotherapy, Imiquimod

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • DermResearch @ 888 Inc
  • Windsor Clinical Research
  • Centre de Recherche Dermatologique, CRDQ

Outcomes

Primary Outcome Measures

Recurrence rate and time to recurrence of lesions

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2005
Last Updated
April 21, 2008
Sponsor
Derm Research @ 888 Inc.
Collaborators
3M
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1. Study Identification

Unique Protocol Identification Number
NCT00110682
Brief Title
Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses
Official Title
A Randomized, Parallel-Group, Vehicle-Controlled, Double-Blind Study of Topical Imiquimod 5% Cream Used as an Adjunct to Cryotherapy in the Management of Actinic Keratoses, With a Long-Term (1 Year) Follow-Up
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Derm Research @ 888 Inc.
Collaborators
3M

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratosis, Actinic Keratosis
Keywords
Actinic Keratosis, Cryotherapy, Imiquimod

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Imiquimod used as an adjunct to cryotherapy
Primary Outcome Measure Information:
Title
Recurrence rate and time to recurrence of lesions
Secondary Outcome Measure Information:
Title
Time to reach treatment success
Title
Percentage of patients who clear
Title
Patient improvement assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Poulin, MD FRCPC
Organizational Affiliation
Centre de Recherche Dermatologique du Quebec Metropolitaine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jerry KL Tan, MD FDRPC
Organizational Affiliation
U. of Western Ontario, Windsor Ontario
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Thomas, MD FRCPC
Organizational Affiliation
Derm Research @ 888 Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
DermResearch @ 888 Inc
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V4C 6X4
Country
Canada
Facility Name
Windsor Clinical Research
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
Centre de Recherche Dermatologique, CRDQ
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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