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Sponsors and Collaborators: |
University of Arizona National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00619060 |
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of topical myristyl nicotinate cream may stop skin cancer from forming.
PURPOSE: This randomized phase I trial is studying the side effects and best way to give topical myristyl nicotinate cream on the skin of healthy volunteers.
Condition | Intervention | Phase |
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Healthy, no Evidence of Disease Non-Melanomatous Skin Cancer |
Drug: topical myristyl nicotinate cream Other: placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase I Study of Topical Myristyl Nicotinate Cream on Human Skin in Healthy Volunteers |
Estimated Enrollment: | 25 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Participants apply topical myristyl nicotinate to one forearm and topical placebo to the other forearm once daily for 4 weeks.
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Drug: topical myristyl nicotinate cream
Applied topically
Other: placebo
Applied topically
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Arm II: Experimental
Participants receive treatment as in arm I but on opposite forearms.
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Drug: topical myristyl nicotinate cream
Applied topically
Other: placebo
Applied topically
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OBJECTIVES:
OUTLINE: Participants are randomized to 1 of 2 treatment arms and serve as their own controls.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to any of the following:
PRIOR CONCURRENT THERAPY:
United States, Arizona | |
Arizona Cancer Center at University of Arizona Health Sciences Center | |
Tucson, Arizona, United States, 85724-5024 |
Study Chair: | Clara Curiel, MD | University of Arizona |
Study ID Numbers: | CDR0000582627, UARIZ-BIO-07-085 |
Study First Received: | February 19, 2008 |
Last Updated: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00619060 History of Changes |
Health Authority: | United States: Food and Drug Administration |
skin cancer healthy, no evidence of disease |
Antimetabolites Vasodilator Agents Niacinamide Vitamin B Complex Skin Diseases Antilipemic Agents Trace Elements |
Healthy Cardiovascular Agents Skin Neoplasms Nicotinic Acids Vitamins Micronutrients Niacin |
Antimetabolites Vasodilator Agents Vitamin B Complex Skin Diseases Molecular Mechanisms of Pharmacological Action Growth Substances Antilipemic Agents Physiological Effects of Drugs Cardiovascular Agents |
Skin Neoplasms Pharmacologic Actions Nicotinic Acids Neoplasms Neoplasms by Site Vitamins Therapeutic Uses Micronutrients Niacin |