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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Topical Myristyl Nicotinate Cream; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Myristyl (right), Placebo (Left); Participants apply topical myristyl nicotinate to the right forearm and topical placebo to the left forearm once daily for 4 weeks; Myristyl (Right), Placebo (Left) Topical Myristyl Nicotinate Cream and Placebo	Drug: Topical Myristyl Nicotinate Cream; Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks.; Other Names: Cream; Myristyl; Nicotinate; Drug: Placebo; Participants apply topical placebo to one forearm once daily for 4 weeks.
EXPERIMENTAL: Myristyl (Left), Placebo (Right); Participants apply topical myristyl nicotinate to the left forearm and topical placebo to the right forearm once daily for 4 weeks; Myristyl (Left), Placebo (Right)Topical Myristyl Nicotinate Cream and Placebo	Drug: Topical Myristyl Nicotinate Cream; Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks.; Other Names: Cream; Myristyl; Nicotinate; Drug: Placebo; Participants apply topical placebo to one forearm once daily for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Adverse Events by Treatment.	Comparison of number of participants with adverse events by treatment.	30 Days

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Clara Curiel, MD, University of Arizona

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (ACTUAL): July 1, 2008
• Study Completion (ACTUAL): July 1, 2008

Study Registration Dates

• First Submitted: February 19, 2008
• First Submitted That Met QC Criteria: February 19, 2008
• First Posted (ESTIMATE): February 20, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 10, 2016
• Last Update Submitted That Met QC Criteria: March 9, 2016
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: skin cancer; healthy, no evidence of disease
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacin
• Other Study ID Numbers: CDR0000582627; P30CA023074 (U.S. NIH Grant/Contract); UARIZ-BIO-07-085 (OTHER: UA IRB No.)