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Clinical Trial 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.


Clinical Trial 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 ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00110682
Study type Interventional
Source Derm Research @ 888 Inc.
Contact
Status Completed
Phase Phase 4
Start date April 2005
Completion date December 2006

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