Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy, no Evidence of Disease Non-melanomatous Skin Cancer	Drug: topical myristyl nicotinate cream Other: placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Phase I Study of Topical Myristyl Nicotinate Cream on Human Skin in Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Cancer Skin Cancer

Drug Information available for: Niacin

U.S. FDA Resources

Further study details as provided by University of Arizona:

Primary Outcome Measures:

Safety of myristyl nicotinate at the administered doses [ Designated as safety issue: Yes ]

Enrollment:	22
Study Start Date:	August 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Participants apply topical myristyl nicotinate to one forearm and topical placebo to the other forearm once daily for 4 weeks.	Drug: topical myristyl nicotinate cream Applied topically Other: placebo Applied topically
Experimental: Arm II Participants receive treatment as in arm I but on opposite forearms.	Drug: topical myristyl nicotinate cream Applied topically Other: placebo Applied topically

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Healthy volunteers who have not used topical medications to the skin of the upper extremities, except for emollients or sunscreens, for at least 30 days prior to study entry

PATIENT CHARACTERISTICS:

Must agree to limit sun exposure as much as possible and wear protective clothing on the forearms in place of using sunscreens or moisturizers
Female participants must be surgically sterile by hysterectomy or post menopausal for at least 1 year
No signs of inflammation or irritation of the skin on the forearms
No prior history of actinic keratosis or skin cancer on the forearm
No known immunosuppression by virtue of medication or disease, including AIDS patients
No uncontrolled intercurrent illness including, but not limited to any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
No psychiatric illness/social situations that would limit compliance with study requirements
No invasive cancer within the past 5 years
No skin conditions felt by the study physician to contraindicate enrollment including, but not limited to, psoriasis or atopic dermatitis within a proposed treatment area

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No concurrent therapy (e.g., retinoids, fluorouracil) on the forearms that may interfere with clinical evaluations
More than 30 days since prior and no concurrent or planned participation in another clinical trial
No concurrent oral supplemental niacin, by itself or in the form of a multi-vitamin that exceeds 40 mg/day
No concurrent oral prednisone
No concurrent immunosuppressants/immunomodulators (e.g., cyclosporine, chemotherapeutic agents, or biologic therapy)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619060

Locations

United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024

Sponsors and Collaborators

University of Arizona

National Cancer Institute (NCI)

Investigators

Study Chair:

Clara Curiel, MD

University of Arizona

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Clara Curiel, M.D., Arizona Cancer Center at University of Arizona Health Science Center
ClinicalTrials.gov Identifier:	NCT00619060 History of Changes
Other Study ID Numbers:	CDR0000582627, P30CA023074, UARIZ-BIO-07-085
Study First Received:	February 19, 2008
Last Updated:	September 28, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Arizona:

skin cancer
healthy, no evidence of disease

Additional relevant MeSH terms:

Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Niacin
Nicotinic Acids
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013