Status:
COMPLETED
Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 tr...
Detailed Description
OBJECTIVES: * To determine if topical myristyl nicotinate (MN) is a safe, tolerable treatment in healthy volunteers. * To determine if topically administered MN cream is associated with any significa...
Eligibility Criteria
Inclusion
- Subjects 18 years of age or older with normal skin
- Have used no topical medications on the skin of the upper extremities, except for emollients or sunscreens, for at least 30 days prior to study entry
- Agree to limit sun exposure as much as possible and wear protective clothing on the forearms in place of using sunscreens or moisturizers
- Ability to understand and willingness to sign an informed consent before initiation of therapy after the nature of the study has been explained to them
- Females must be surgically sterile by hysterectomy or post menopausal
Exclusion
- Subjects with no signs of inflammation or irritation of the skin on the forearms
- Subjects with prior history of actinic keratosis or skin cancer on the forearm
- Females of child bearing potential
- Subjects with any concurrent therapy (e.g., retinoids, fluorouracil) on the forearms that may interfere with clinical evaluations
- Subjects taking oral supplemental niacin, by itself or in the form of a multi-vitamin that exceeds 40 mg/day
- No known immunosuppression by virtue of medication or disease, including AIDS patients, subjects taking oral prednisone, and subjects on immunosuppressants/immunomodulators( cyclosporine, chemotherapeutic agents, or biologic therapy), determined by the examining investigator/co-investigator
- Uncontrolled intercurrent illness including, but not limited to any of ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Subjects who have had invasive cancer within the past 5 years
- Skin conditions felt by the study physician to contraindicate enrollment including, but not limited to, psoriasis or atopic dermatitis within a proposed treatment area
- Less than 30 days since prior and no concurrent or planned participation in another clinical trial
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00619060
Start Date
August 1 2007
End Date
July 1 2008
Last Update
March 10 2016
Active Locations (1)
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1
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024