Topical Perillyl Alcohol in Treating Patients With Sun Damaged Skin and Actinic Keratoses

NCT00608634 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2015-04-01

Study results available
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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.

Conditions

  • Precancerous Condition

Interventions

DRUG

perillyl alcohol

Applied as topical cream

OTHER

placebo

Applied as topical cream

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Arizona Disease Control Research Commission

    collaborator OTHER_GOV
  • University of Arizona

    lead OTHER

Principal Investigators

  • Steve Stratton, PhD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2008-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00608634 on ClinicalTrials.gov