Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT00619060
Status:
COMPLETED
Last Update Posted:
2016-03-10
First Post:
2008-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers
Sponsor:
University of Arizona
Organization:
Study Overview
Official Title:
A Phase I Study of Topical Myristyl Nicotinate Cream on Human Skin in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA023074 | NIH | None | https://reporter.nih.gov/quic… | View |
| UARIZ-BIO-07-085 | OTHER | UA IRB No. | View |