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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00110682
Recruitment Status : Completed
First Posted : May 13, 2005
Last Update Posted : April 24, 2008
Sponsor:
Collaborator:
3M
Information provided by:
Derm Research @ 888 Inc.

Tracking Information
First Submitted Date  ICMJE May 12, 2005
First Posted Date  ICMJE May 13, 2005
Last Update Posted Date April 24, 2008
Study Start Date  ICMJE April 2005
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Recurrence rate and time to recurrence of lesions
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Time to reach treatment success
  • Percentage of patients who clear
  • Patient improvement assessment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Keratosis
  • Actinic Keratosis
Intervention  ICMJE Drug: Imiquimod used as an adjunct to cryotherapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00110682
Other Study ID Numbers  ICMJE DR 2004-05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party D Richard Thomas, Department of Dermatology and Skin Science
Study Sponsor  ICMJE Derm Research @ 888 Inc.
Collaborators  ICMJE 3M
Investigators  ICMJE
Principal Investigator: 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.
PRS Account Derm Research @ 888 Inc.
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP