NCT00110682

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Derm Research @ 888 Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Keratosis
• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Imiquimod used as an adjunct to cryotherapy

Timeline

• Start date: 2005-04-01
• Primary completion: 2006-10-01
• Completion: 2006-12-01
• First posted: 2005-05-13
• Last updated: 2008-04-24

Locations

3 sites across 1 country: Canada