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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Keratosis; Actinic Keratosis	Drug: Imiquimod used as an adjunct to cryotherapy	Phase 4

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

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
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 Start Date :	April 2005
Actual Primary Completion Date :	October 2006
Actual Study Completion Date :	December 2006

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Recurrence rate and time to recurrence of lesions

Secondary Outcome Measures :

1. Time to reach treatment success
2. Percentage of patients who clear
3. Patient improvement assessment

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Canada, British Columbia
DermResearch @ 888 Inc
Vancouver, British Columbia, Canada, V4C 6X4
Canada, Ontario
Windsor Clinical Research
Windsor, Ontario, Canada
Canada, Quebec
Centre de Recherche Dermatologique, CRDQ
Sainte-Foy, Quebec, Canada, G1V 4X7

Sponsors and Collaborators

Derm Research @ 888 Inc.

3M

Investigators

Principal Investigator:	Yves Poulin, MD FRCPC	Centre de Recherche Dermatologique du Quebec Metropolitaine
Principal Investigator:	Jerry KL Tan, MD FDRPC	U. of Western Ontario, Windsor Ontario
Principal Investigator:	Richard Thomas, MD FRCPC	Derm Research @ 888 Inc.

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	D Richard Thomas, Department of Dermatology and Skin Science
ClinicalTrials.gov Identifier:	NCT00110682 History of Changes
Other Study ID Numbers:	DR 2004-05
First Posted:	May 13, 2005
Last Update Posted:	April 24, 2008
Last Verified:	April 2008

Keywords provided by Derm Research @ 888 Inc.:

Actinic Keratosis; Cryotherapy; Imiquimod

Additional relevant MeSH terms:

Keratosis; Keratosis, Actinic; Skin Diseases; Precancerous Conditions; Neoplasms; Imiquimod	Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Antineoplastic Agents; Interferon Inducers