Expired Study
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Tucson, Arizona 85724


Purpose:

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.


Study summary:

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 significant local or systemic toxicity in normal human subjects in a one-month period. OUTLINE: Participants are randomized to 1 of 2 treatment arms and serve as their own controls. - Arm I: Participants apply topical myristyl nicotinate to one forearm and topical placebo to the other forearm once daily for 4 weeks. - Arm II: Participants receive treatment as in arm I but on opposite forearms. All participants undergo blood collection for chemistry analysis (SMA-20 and CBC) at baseline and at 2 and 4 weeks.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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


NCT ID:

NCT00619060


Primary Contact:

Study Chair
Clara Curiel, MD
University of Arizona


Backup Contact:

N/A


Location Contact:

Tucson, Arizona 85724
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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