Phase 1
N=22
Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00619060 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Participants With Adverse Events by Treatment. — 8; 2 participants — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Topical Myristyl Nicotinate Cream (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arizona
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Adverse Events by Treatment. |
8; 2 | 0.01 sig |
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
Data sourced from ClinicalTrials.gov (NCT00619060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.