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

February 19, 2008
March 9, 2016
August 2007
July 2008   (final data collection date for primary outcome measure)
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.
Safety of myristyl nicotinate at the administered doses [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00619060 on ClinicalTrials.gov Archive Site
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Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers
A Phase I Study of Topical Myristyl Nicotinate Cream on Human Skin in Healthy Volunteers

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.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Healthy
  • 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 (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
    Interventions:
    • Drug: Topical Myristyl Nicotinate Cream
    • Drug: Placebo
  • 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
    Interventions:
    • Drug: Topical Myristyl Nicotinate Cream
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00619060
CDR0000582627, P30CA023074, UARIZ-BIO-07-085
Yes
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University of Arizona
University of Arizona
National Cancer Institute (NCI)
Study Chair: Clara Curiel, MD University of Arizona
University of Arizona
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP