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


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

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Trial Information

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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
entry

PATIENT CHARACTERISTICS:

- 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
patients

- No uncontrolled intercurrent illness including, but not limited to any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- No psychiatric illness/social situations that would limit compliance with study
requirements

- 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

PRIOR CONCURRENT THERAPY:

- 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:

Interventional

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:

Yes

Principal Investigator

Clara Curiel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000582627

NCT ID:

NCT00619060

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

Name

Location

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