Spots Global Cancer Trial Database for Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses

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Trial Identification

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

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 ID: NCT00110682

Conditions

Keratosis

Actinic Keratosis

Interventions

Imiquimod used as an adjunct to cryotherapy

Study Description

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.

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