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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.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Keratosis Actinic Keratosis Drug: Imiquimod used as an adjunct to cryotherapy Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Recurrence rate and time to recurrence of lesions

Secondary Outcome Measures :
  1. Time to reach treatment success
  2. Percentage of patients who clear
  3. Patient improvement assessment

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110682


Locations
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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
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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
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Responsible Party: D Richard Thomas, Department of Dermatology and Skin Science
ClinicalTrials.gov Identifier: NCT00110682    
Other Study ID Numbers: DR 2004-05
First Posted: May 13, 2005    Key Record Dates
Last Update Posted: April 24, 2008
Last Verified: April 2008
Keywords provided by Derm Research @ 888 Inc.:
Actinic Keratosis
Cryotherapy
Imiquimod
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Imiquimod
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers