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Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00619060
First received: February 19, 2008
Last updated: September 28, 2010
Last verified: September 2010

February 19, 2008
September 28, 2010
August 2007
July 2008   (final data collection date for primary outcome measure)
Safety of myristyl nicotinate at the administered doses [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00619060 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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, no Evidence of Disease
  • Non-melanomatous Skin Cancer
  • Drug: topical myristyl nicotinate cream
    Applied topically
  • Other: placebo
    Applied topically
  • Experimental: Arm I
    Participants apply topical myristyl nicotinate to one forearm and topical placebo to the other forearm once daily for 4 weeks.
    Interventions:
    • Drug: topical myristyl nicotinate cream
    • Other: placebo
  • Experimental: Arm II
    Participants receive treatment as in arm I but on opposite forearms.
    Interventions:
    • Drug: topical myristyl nicotinate cream
    • Other: 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)

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)
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00619060
CDR0000582627, P30CA023074, UARIZ-BIO-07-085
Not Provided
Clara Curiel, M.D., Arizona Cancer Center at University of Arizona Health Science Center
University of Arizona
National Cancer Institute (NCI)
Study Chair: Clara Curiel, MD University of Arizona
University of Arizona
September 2010

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