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