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Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00619060
First received: February 19, 2008
Last updated: March 9, 2016
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Topical Myristyl Nicotinate Cream
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase I Study of Topical Myristyl Nicotinate Cream on Human Skin in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Participants With Adverse Events by Treatment. [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    Comparison of number of participants with adverse events by treatment.


Enrollment: 22
Study Start Date: August 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Myristyl (right), Placebo (Left)
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
Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks.
Other Names:
  • Myristyl
  • Nicotinate
  • Cream
Drug: Placebo
Participants apply topical placebo to one forearm once daily for 4 weeks.
Experimental: Myristyl (Left), Placebo (Right)
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
Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks.
Other Names:
  • Myristyl
  • Nicotinate
  • Cream
Drug: Placebo
Participants apply topical placebo to one forearm once daily for 4 weeks.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619060

Locations
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
Investigators
Study Chair: Clara Curiel, MD University of Arizona
  More Information

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00619060     History of Changes
Other Study ID Numbers: CDR0000582627  P30CA023074  UARIZ-BIO-07-085 
Study First Received: February 19, 2008
Results First Received: November 27, 2013
Last Updated: March 9, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arizona:
skin cancer
healthy, no evidence of disease

Additional relevant MeSH terms:
Niacin
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016