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Phase 1 N=22 Randomized Quadruple-blind Prevention

Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers

Healthy

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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