NCT00619060

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 trial is studying the side effects and best way to give topical myristyl nicotinate cream on the skin of healthy volunteers.

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 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Topical Myristyl Nicotinate Cream	Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks.
DRUG	Placebo	Participants apply topical placebo to one forearm once daily for 4 weeks.

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-02-20
• Last updated: 2016-03-10
• Results posted: 2016-03-10

Locations

1 site across 1 country: United States