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
• 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

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

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