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Tracking Information | |||||
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First Received Date † | January 22, 2008 | ||||
Last Updated Date | March 19, 2009 | ||||
Start Date † | January 2007 | ||||
Current Primary Outcome Measures † |
Percentage of patients who have 10% or greater reduction in average nuclear abnormality (ANA) as shown by karyometric analysis of skin biopsies before and after treatment [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00601640 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin | ||||
Official Title † | Phase IIB Study to Evaluate the Safety and Efficacy of Topical Difluoromethylornithine and Topical Diclofenac in the Treatment of Sun-Damaged Skin on the Forearm | ||||
Brief Summary | RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of eflornithine and diclofenac may stop cancer from growing in patients with sun-damaged skin. PURPOSE: This randomized phase II trial is studying the side effects and how well eflornithine works compared with diclofenac, given alone or together, in treating patients with sun-damaged skin. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
Digital photographs are taken at baseline and 1-2 weeks after completion of study therapy to document improvement of sun damage, appearance of new skin lesions, and toxicity. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized | ||||
Condition † | Non-Melanomatous Skin Cancer | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 138 | ||||
Completion Date | |||||
Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 40 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00601640 | ||||
Responsible Party | |||||
Secondary IDs †† | UARIZ-BIO-06182 | ||||
Study Sponsor † | University of Arizona | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | March 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |