Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers
Condition: Healthy
Intervention: Topical Myristyl Nicotinate Cream; Placebo
Intervention description: Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks.; Participants apply topical placebo to one forearm once daily for 4 weeks.
Intervention MeSH terms: Niacin; Nicotinic Acids
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: skin cancer; healthy, no evidence of disease

Summary:

      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.
    

Eligibility 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