Cellular and Molecular Events During Treatment of Actinic Keratosis With Imiquimod 5% Cream
Double-Blind, Vehicle-Controlled Study to Evaluate Cellular and Molecular Events During Four Weeks of Treatment for Actinic Keratosis With Aldara (Imiquimod) Cream, 5%
1 other identifier
interventional
17
1 country
1
Brief Summary
Treatment of actinic keratosis with imiquimod cream is expected to cause changes in the genes that are turned on, and turned off, by skin cells. Some of the drug induced changes in skin cells should also be visible using a special microscope. This study examines both types of changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2003
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 8, 2006
CompletedFirst Posted
Study publicly available on registry
June 9, 2006
CompletedJuly 23, 2010
July 1, 2010
6 months
June 8, 2006
July 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gene expression profiling of treated lesions
weeks 1, 2, and 4, and at 4 weeks post-treatment
Secondary Outcomes (1)
Confocal microscopic evaluation before, during and post treatment
weeks 1, 2, 4 and at 4 weeks post-treatment
Study Arms (2)
Imiquimod cream
ACTIVE COMPARATORImiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream Applied 3 times per week for 4 weeks
Vehicle cream
PLACEBO COMPARATORVehicle cream 250 mg Applied 3 times per week for 4 weeks
Interventions
Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream
Eligibility Criteria
You may qualify if:
- Have actinic keratoses on balding scalp
- Discontinuation of tanning bed use
- Discontinuation of moisturizers
- Avoidance of retinol products
You may not qualify if:
- Uncontrolled, clinically significant medical condition
- Dermatologic disease other than actinic keratosis in treatment area
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loma Linda University Medical Center
Loma Linda, California, 92350, United States
Related Publications (2)
Torres A, Storey L, Anders M, Miller RL, Bulbulian BJ, Jin J, Raghavan S, Lee J, Slade HB, Birmachu W. Microarray analysis of aberrant gene expression in actinic keratosis: effect of the Toll-like receptor-7 agonist imiquimod. Br J Dermatol. 2007 Dec;157(6):1132-47. doi: 10.1111/j.1365-2133.2007.08218.x. Epub 2007 Oct 18.
PMID: 17944981BACKGROUNDTorres A, Storey L, Anders M, Miller RL, Bulbulian BJ, Jin J, Raghavan S, Lee J, Slade HB, Birmachu W. Immune-mediated changes in actinic keratosis following topical treatment with imiquimod 5% cream. J Transl Med. 2007 Jan 26;5:7. doi: 10.1186/1479-5876-5-7.
PMID: 17257431BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
TC Meng, MD
Graceway Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 8, 2006
First Posted
June 9, 2006
Study Start
January 1, 2003
Primary Completion
July 1, 2003
Study Completion
July 1, 2003
Last Updated
July 23, 2010
Record last verified: 2010-07