Healthy
Conditions
Keywords
skin cancer, healthy, no evidence of disease
Brief 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.
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.
Interventions
DRUGTopical Myristyl Nicotinate Cream
Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks.
DRUGPlacebo
Participants apply topical placebo to one forearm once daily for 4 weeks.
Sponsors
National Cancer Institute (NCI)
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Adverse Events by Treatment. | 30 Days | Comparison of number of participants with adverse events by treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Myristyl, Placebo Participants apply topical myristyl nicotinate to the and topical placebo to the other forearm once daily for 4 weeks; Myristyl, Placebo
Topical Myristyl Nicotinate Cream and Placebo : Applied topically | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Myristyl, Placebo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 50 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 22 | 2 / 22 | 8 / 22 | 1 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
Participants With Adverse Events by Treatment.
Comparison of number of participants with adverse events by treatment.
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Myristyl Nicotinate Cream | Participants With Adverse Events by Treatment. | 8 participants |
| Topical Placebo Cream | Participants With Adverse Events by Treatment. | 2 participants |
p-value: 0.01Binomial