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

This study has been completed.
Sponsor:
Collaborator:
3M
Information provided by:
Derm Research @ 888 Inc.
ClinicalTrials.gov Identifier:
NCT00110682
First received: May 12, 2005
Last updated: April 21, 2008
Last verified: April 2008
History of Changes

May 12, 2005
April 21, 2008
April 2005
October 2006   (final data collection date for primary outcome measure)
Recurrence rate and time to recurrence of lesions
Same as current
Complete list of historical versions of study NCT00110682 on ClinicalTrials.gov Archive Site
  • Time to reach treatment success
  • Percentage of patients who clear
  • Patient improvement assessment
Same as current
Not Provided
Not Provided
 
Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses
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 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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Keratosis
  • Actinic Keratosis
Drug: Imiquimod used as an adjunct to cryotherapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2006
October 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00110682
DR 2004-05
Yes
D Richard Thomas, Department of Dermatology and Skin Science
Derm Research @ 888 Inc.
3M
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.
Derm Research @ 888 Inc.
April 2008

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