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

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

Drug Information available for: Imiquimod

Genetic and Rare Diseases Information Center resources: Tylosis

U.S. FDA Resources

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

Primary Outcome Measures:

Recurrence rate and time to recurrence of lesions

Secondary Outcome Measures:

Time to reach treatment success
Percentage of patients who clear
Patient improvement assessment


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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided


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
Study First Received:	May 12, 2005
Last Updated:	April 21, 2008
Health Authority:	Canada: Health Canada

Keywords provided by Derm Research @ 888 Inc.:


Actinic Keratosis Cryotherapy Imiquimod

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on March 03, 2015