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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00619060 |
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Date of registration:
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19/02/2008 |
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Primary sponsor: |
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Public title:
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Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers
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Scientific title:
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A Phase I Study of Topical Myristyl Nicotinate Cream on Human Skin in Healthy Volunteers |
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Date of first enrolment:
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August 2007 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00619060 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Clara Curiel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Arizona |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy, no Evidence of Disease
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Non-melanomatous Skin Cancer
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Intervention(s)
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Drug: topical myristyl nicotinate cream
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Other: placebo
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Primary Outcome(s)
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Safety of myristyl nicotinate at the administered doses
[Time Frame: Yes]
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Secondary ID(s)
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CDR0000582627
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P30CA023074
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UARIZ-BIO-07-085
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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