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NCT00608634 · ClinicalTrials.gov registry record · Phase 2
Topical Perillyl Alcohol in Treating Patients With Sun Damaged Skin and Actinic Keratoses
A Phase 2 study, sponsored by University of Arizona.
- Completed
- Registry status
- Phase 2
- Development phase
- 89
- Enrollment target
NCT00608634: Completed Phase 2 study, sponsored by University of Arizona.
NCT00608634 is a Phase 2 study that has completed, run by University of Arizona. The registered enrollment target is 89 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00608634, a Phase 2 study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 89 participants
- Enrollment target
Study 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.
Primary Outcome
The histopathologic scoring for skin biopsies from sun-damaged skin to assess the following seven characteristics: 1- atypia (levels 0, 1 \& 2), 2- inflammation (grades 0, 1 \& 2), 3- hyperkeratosis (loss of basket weave pattern of stratum corneum), 4- parakeratosis (present when there were \>3 characteristic nuclei per 40:1 field in stratum corneum), 5- dyskeratosis (focal presence of cells with homogenous, pink cytoplasm n pyknotic nuclei), 6- epidermotropism (lymphocytes migration of \>3 cell
Interventions
- OTHER placebo
- DRUG perillyl alcohol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2004-05 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
What the finished NCT00608634 record still lists
NCT00608634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00608634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00608634 about?
NCT00608634 is a clinical study titled "Topical Perillyl Alcohol in Treating Patients With Sun Damaged Skin and Actinic Keratoses". 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 can...
What is the current status of trial NCT00608634?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2004-05. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00608634?
The interventions under investigation include: placebo (OTHER), perillyl alcohol (DRUG).
Who is sponsoring clinical trial NCT00608634?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00608634's enrollment target sits among peer trials
89 802nd of 2000 higher than 1,198 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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