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
Evaluation of: (i) topical imiquimod 5% cream or (ii) vehicle cream used two times weekly
for eight weeks starting two weeks post cryotherapy.
- To assess and compare the recurrence rate and time to recurrence of the 2 different
- 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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Recurrence rate and time to recurrence of lesions
Yves Poulin, MD FRCPC
Centre de Recherche Dermatologique du Quebec Metropolitaine
Canada: Health Canada