Status:
COMPLETED
Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses
Lead Sponsor:
Derm Research @ 888 Inc.
Collaborating Sponsors:
3M
Conditions:
Keratosis
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 d...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00110682
Start Date
April 1 2005
End Date
December 1 2006
Last Update
April 24 2008
Active Locations (3)
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1
DermResearch @ 888 Inc
Vancouver, British Columbia, Canada, V4C 6X4
2
Windsor Clinical Research
Windsor, Ontario, Canada
3
Centre de Recherche Dermatologique, CRDQ
Sainte-Foy, Quebec, Canada, G1V 4X7