Actinic Keratosis Clinical Trial
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 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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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