Clinical trial NCT00619060: Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers
Official title: A Phase I Study of Topical Myristyl Nicotinate Cream on Human Skin in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: skin cancer
healthy, no evidence of disease
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-02-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participants With Adverse Events by Treatment.
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center at University of Arizona Health Sciences Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Clara Curiel, MD
role: STUDY_CHAIR
References: