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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
  Purpose

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.


Condition Intervention Phase
Keratosis
Actinic Keratosis
 Drug: Imiquimod used as an adjunct to cryotherapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Imiquimod
U.S. FDA Resources

Further study details as provided by Derm Research @ 888 Inc.:

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

Estimated Enrollment: 60
Study Start Date: April 2005
Study Completion Date: December 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110682

Locations
Canada, British Columbia
DermResearch @ 888 Inc
Vancouver, British Columbia, Canada, V4C 6X4
Canada, Ontario
Windsor Clinical Research
Windsor, Ontario, Canada
Canada, Quebec
Centre de Recherche Dermatologique, CRDQ
Sainte-Foy, Quebec, Canada, G1V 4X7
Sponsors and Collaborators
Derm Research @ 888 Inc.
3M
Investigators
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.
  More Information

No publications provided

Responsible Party: D Richard Thomas, Department of Dermatology and Skin Science
ClinicalTrials.gov Identifier: NCT00110682     History of Changes
Other Study ID Numbers: DR 2004-05
Study First Received: May 12, 2005
Last Updated: April 21, 2008
Health Authority: Canada: Health Canada

Keywords provided by Derm Research @ 888 Inc.:
Actinic Keratosis
Cryotherapy
Imiquimod

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Ichthyosis
Keratoacanthoma
Skin Diseases
Precancerous Conditions
Neoplasms
Skin Abnormalities
Congenital Abnormalities
 Infant, Newborn, Diseases
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on June 18, 2013