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

Phase 1
18 Years
Not Enrolling
Healthy, no Evidence of Disease, Non-melanomatous Skin Cancer

Thank you

Trial Information

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


- 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

- 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.

Inclusion Criteria


- 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


- 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


- 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)

Type of Study:


Study Design:

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

Outcome Measure:

Safety of myristyl nicotinate at the administered doses

Safety Issue:


Principal Investigator

Clara Curiel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

July 2008

Related Keywords:

  • Healthy, no Evidence of Disease
  • Non-melanomatous Skin Cancer
  • skin cancer
  • healthy, no evidence of disease
  • Skin Neoplasms



Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724