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Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses
This study has been completed.
Sponsor:
Derm Research @ 888 Inc.
Collaborator:
3M
Information provided by:
Derm Research @ 888 Inc.
ClinicalTrials.gov Identifier:
NCT00110682
First received: May 12, 2005
Last updated: April 21, 2008
Last verified: April 2008
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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 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:
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) |
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 (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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00110682
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: | 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 |
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 |
ClinicalTrials.gov processed this record on June 23, 2017