Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00619060

Run by

University of Arizona

People needed

22

Starts

2007-08-01

Expected to finish

2008-07-01

Last updated by the study team

2016-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Cancer Center at University of Arizona Health Sciences Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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