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NCT00110682 Clinical Trial

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

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00110682
Other study ID # DR 2004-05
Secondary ID
Status Completed
Phase Phase 4
First received May 12, 2005
Last updated April 21, 2008
Start date April 2005
Est. completion date December 2006

Study information
Verified date April 2008
Source Derm Research @ 888 Inc.
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

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.

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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of actinic keratosis with 4 or more discreet lesions on the face or balding scalp. Lesions must be within a treatment area not exceeding 50 cm2 (combined total must not exceed 50 cm2)

- Women of childbearing potential using appropriate contraceptive methods

Exclusion Criteria:

- Previous treatments with imiquimod for AK in the prescribed area within the past 5 months or cryosurgery in the same area within the past 4 weeks.

- Patients unwilling to stay out of the sun or wear protective clothing or to use sunscreen with a minimum of SPF 15 during the study.

- Basal or squamous cell carcinomas in the prescribed treatment area in the past 2 years.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Imiquimod used as an adjunct to cryotherapy

Locations
Country Name City State
Canada Centre de Recherche Dermatologique, CRDQ Sainte-Foy Quebec
Canada DermResearch @ 888 Inc Vancouver British Columbia
Canada Windsor Clinical Research Windsor Ontario

Sponsors (2)
Lead Sponsor Collaborator
Derm Research @ 888 Inc. 3M

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence rate and time to recurrence of lesions
Secondary Time to reach treatment success
Secondary Percentage of patients who clear
Secondary Patient improvement assessment
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