DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers

Information source: University of Arizona
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy, no Evidence of Disease; Non-melanomatous Skin Cancer

Intervention: topical myristyl nicotinate cream (Drug); placebo (Other)

Phase: Phase 1

Status: Completed

Sponsored by: University of Arizona

Official(s) and/or principal investigator(s):
Clara Curiel, MD, Study Chair, Affiliation: University of Arizona


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Safety of myristyl nicotinate at the administered doses

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- Healthy volunteers who have not used topical medications to the skin of the upper

extremities, except for emollients or sunscreens, for at least 30 days prior to study entry PATIENT CHARACTERISTICS:

- Must agree to limit sun exposure as much as possible and wear protective clothing on

the forearms in place of using sunscreens or moisturizers

- Female participants must be surgically sterile by hysterectomy or post menopausal for

at least 1 year

- No signs of inflammation or irritation of the skin on the forearms

- No prior history of actinic keratosis or skin cancer on the forearm

- No known immunosuppression by virtue of medication or disease, including AIDS


- No uncontrolled intercurrent illness including, but not limited to any of the


- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- No psychiatric illness/social situations that would limit compliance with study


- No invasive cancer within the past 5 years

- No skin conditions felt by the study physician to contraindicate enrollment

including, but not limited to, psoriasis or atopic dermatitis within a proposed treatment area PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No concurrent therapy (e. g., retinoids, fluorouracil) on the forearms that may

interfere with clinical evaluations

- More than 30 days since prior and no concurrent or planned participation in another

clinical trial

- No concurrent oral supplemental niacin, by itself or in the form of a multi-vitamin

that exceeds 40 mg/day

- No concurrent oral prednisone

- No concurrent immunosuppressants/immunomodulators (e. g., cyclosporine,

chemotherapeutic agents, or biologic therapy)

Locations and Contacts

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona 85724-5024, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: August 2007
Last updated: September 28, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017