Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses - Full Text View

Sponsors and Collaborators:	Derm Research @ 888 Inc. 3M
Information provided by:	Derm Research @ 888 Inc.
ClinicalTrials.gov Identifier:	NCT00110682

Purpose

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	Intervention	Phase
Keratosis Actinic Keratosis	Drug: Imiquimod used as an adjunct to cryotherapy	Phase IV

Drug Information available for: S 26308

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Derm Research @ 888 Inc.:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	60
Study Start Date:	April 2005
Study Completion Date:	December 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

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

Eligibility

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110682

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

Responsible Party:	Department of Dermatology and Skin Science ( D Richard Thomas )
Study ID Numbers:	DR 2004-05
Study First Received:	May 12, 2005
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00110682
Health Authority:	Canada: Health Canada

Keywords provided by Derm Research @ 888 Inc.:

Actinic Keratosis
Cryotherapy
Imiquimod

Study placed in the following topic categories:

Keratosis
Skin Diseases
Interferons
Imiquimod
Tylosis

Additional relevant MeSH terms:

Interferon Inducers
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009