Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers

A Phase I Study of Topical Myristyl Nicotinate Cream on Human Skin in Healthy Volunteers

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.

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.

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