Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers

NCT00619060 | Completed Phase 1 Results DMC

• 3 other identifiers: CDR0000582627P30CA023074UARIZ-BIO-07-085
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

skin cancer; healthy, no evidence of disease

Outcome Measures

Primary Outcomes (1)

• Participants With Adverse Events by Treatment.

  Comparison of number of participants with adverse events by treatment.

  30 Days

Study Arms (2)

Myristyl (right), Placebo (Left)

EXPERIMENTAL

Participants apply topical myristyl nicotinate to the right forearm and topical placebo to the left forearm once daily for 4 weeks; Myristyl (Right), Placebo (Left) Topical Myristyl Nicotinate Cream and Placebo

Drug: Topical Myristyl Nicotinate Cream; Drug: Placebo

Myristyl (Left), Placebo (Right)

EXPERIMENTAL

Participants apply topical myristyl nicotinate to the left forearm and topical placebo to the right forearm once daily for 4 weeks; Myristyl (Left), Placebo (Right)Topical Myristyl Nicotinate Cream and Placebo

Drug: Topical Myristyl Nicotinate Cream; Drug: Placebo

Interventions

Topical Myristyl Nicotinate Cream DRUG

Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks.

Also known as: Myristyl, Nicotinate, Cream

Myristyl (Left), Placebo (Right); Myristyl (right), Placebo (Left)

Placebo DRUG

Participants apply topical placebo to one forearm once daily for 4 weeks.

Myristyl (Left), Placebo (Right); Myristyl (right), Placebo (Left)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5024, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Niacin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Steve Stratton,PhD Chairman of Scientific Review Comittee
• Organization: University of Arizona

SStratton@uacc.arizona.edu

(520) 626-9295

Study Officials

• Clara Curiel, MD

  University of Arizona

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 20, 2008
• Study Start: August 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 10, 2016
• Results First Posted: March 10, 2016

Record last verified: 2014-09

Locations

US (1)