Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Topical Myristyl Nicotinate Cream
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myristyl (right), Placebo (Left)<br>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<br>* Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks.<br>* Other names: Cream;Drug: Placebo<br>* Participants apply topical placebo to one forearm once daily for 4 weeks.<br>|
| Experimental: Myristyl (Left), Placebo (Right)<br>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<br>* Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks.<br>* Other names: Cream;Drug: Placebo<br>* Participants apply topical placebo to one forearm once daily for 4 weeks.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin cancer, healthy, no evidence of disease