Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00110682 |
Recruitment Status :
Completed
First Posted : May 13, 2005
Last Update Posted : April 24, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 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 |

- Recurrence rate and time to recurrence of lesions
- Time to reach treatment success
- Percentage of patients who clear
- Patient improvement assessment

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110682
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 |
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. |
Responsible Party: | D Richard Thomas, Department of Dermatology and Skin Science |
ClinicalTrials.gov Identifier: | NCT00110682 |
Other Study ID Numbers: |
DR 2004-05 |
First Posted: | May 13, 2005 Key Record Dates |
Last Update Posted: | April 24, 2008 |
Last Verified: | April 2008 |
Actinic Keratosis Cryotherapy Imiquimod |
Keratosis, Actinic Keratosis Skin Diseases Precancerous Conditions Neoplasms Imiquimod |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Interferon Inducers |