Topical Perillyl Alcohol in Treating Patients With Sun Damaged Skin and Actinic Keratoses
Summary
RATIONALE: Drugs used in chemotherapy, such as perillyl alcohol, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. It is not yet known which dose of topical perillyl alcohol is more effective in stopping the development of cancer in sun damaged skin. PURPOSE: This randomized phase II trial is studying high-dose topical perillyl alcohol to see how well it works compared with low-dose topical perillyl alcohol in treating patients with sun damaged skin and actinic keratoses.
Timeline
- Start
- 2004-05
- Primary completion
- 2008-06
- Completion
- 2009-06
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Placebo vs Low Dose POH 0.30%; p = 0.10; Wilcoxon (Mann-Whitney) NCT00608634 ↗
registry analysis (superiority or other test); Placebo vs High Dose POH 0.76%; p = 0.41; Wilcoxon (Mann-Whitney) NCT00608634 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | perillyl alcohol | Small molecule | 0.3 % | Topical |
| Subject | perillyl alcohol | Small molecule | 0.76 % | Topical |