A Phase I Study of Topical Myristyl Nicotinate Cream on Human Skin in Healthy Volunteers
- To determine if topical myristyl nicotinate (MN) is a safe, tolerable treatment in
- 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
- 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.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Safety of myristyl nicotinate at the administered doses
Clara Curiel, MD
University of Arizona
United States: Food and Drug Administration
|Arizona Cancer Center at University of Arizona Health Sciences Center||Tucson, Arizona 85724|