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

This study has been completed.
Information provided by:
Derm Research @ 888 Inc. Identifier:
First received: May 12, 2005
Last updated: April 21, 2008
Last verified: April 2008

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

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00110682

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.
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

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

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

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers processed this record on May 23, 2017