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	Treatment or Intervention	Phase
Keratosis Actinic Keratosis	Drug: Imiquimod used as an adjunct to cryotherapy	Phase III

Further Study Details: 

Primary Outcomes: Recurrence rate and time to recurrence of lesions
Secondary Outcomes: Time to reach treatment success; Percentage of patients who clear; Patient improvement assessment
Expected Total Enrollment:  60

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 above,  Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00110682

Frances Maddin      604-873-4049    trials@dermatologyresearch.com

Canada, British Columbia
      DermResearch @ 888 Inc, Vancouver,  British Columbia,  V4C 6X4,  Canada; Recruiting
Canada, Ontario
      Windsor Clinical Research, Windsor,  Ontario,  Canada; Recruiting
Canada, Quebec
      Centre de Recherche Dermatologique, CRDQ, Sainte-Foy,  Quebec,  G1V 4X7,  Canada; Recruiting

Study chairs or principal investigators

Yves Poulin, MD FRCPC,  Principal Investigator,  Centre de Recherche Dermatologique du Quebec Metropolitaine   
Jerry KL Tan, MD FDRPC,  Principal Investigator,  U. of Western Ontario, Windsor Ontario   
Richard Thomas, MD FRCPC,  Principal Investigator,  Derm Research @ 888 Inc.   

Study ID Numbers:  2004-05
Record last reviewed:  May 2005
Last Updated:  May 12, 2005
Record first received:  May 12, 2005
ClinicalTrials.gov Identifier:  NCT00110682
Health Authority: Canada: Health Canada (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-17