Clinical trial · Interventional
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%
NCT00335179CI-TRIAL-00003698completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aldara (imiquimod 5% cream) | Drug | Imiquimod | ALIAS |
| Vehicle cream | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Imiquimod cream
- description
- Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream Applied 3 times per week for 4 weeks
- interventionNames
- Drug: Aldara (imiquimod 5% cream)
- type
- PLACEBO_COMPARATOR
- label
- Vehicle cream
- description
- Vehicle cream 250 mg Applied 3 times per week for 4 weeks
- interventionNames
- Drug: Vehicle cream
Primary outcomes (1)
- measure
- Gene expression profiling of treated lesions
- timeFrame
- weeks 1, 2, and 4, and at 4 weeks post-treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have actinic keratoses on balding scalp * Discontinuation of tanning bed use * Discontinuation of moisturizers * Avoidance of retinol products Exclusion Criteria: * Uncontrolled, clinically significant medical condition * Dermatologic disease other than actinic keratosis in treatment area
References
Publications (2)
- BACKGROUNDTorres 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 17944981
- BACKGROUNDTorres 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 17257431