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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA023074 | U.S. NIH Grant/Contract | View source | |
| UARIZ-BIO-07-085 | Other Identifier | UA IRB No. |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: Participants are randomized to 1 of 2 treatment arms and serve as their own controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Myristyl Nicotinate Cream | Drug | Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Adverse Events by Treatment. | Comparison of number of participants with adverse events by treatment. | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clara Curiel, MD | University of Arizona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | 85724-5024 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Myristyl (Right), Placebo (Left) | 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 Topical Myristyl Nicotinate Cream and Placebo : Applied topically |
| FG001 | Myristyl (Left), Placebo (Right) | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Myristyl, Placebo | Participants apply topical myristyl nicotinate to the and topical placebo to the other forearm once daily for 4 weeks; Myristyl, Placebo Topical Myristyl Nicotinate Cream and Placebo : Applied topically |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants With Adverse Events by Treatment. | Comparison of number of participants with adverse events by treatment. | Posted | Number | participants | 30 Days |
|
|
4 weeks; Baseline to completion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Both Forearms | Forearms receiving the Myristyl and Placebo, both arms affected |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Stratton,PhD Chairman of Scientific Review Comittee | University of Arizona | (520) 626-9295 | SStratton@uacc.arizona.edu |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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|
| Placebo | Drug | Participants apply topical placebo to one forearm once daily for 4 weeks. |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
|
|
| 0 |
| 22 |
| 1 |
| 22 |
| EG001 | Placebo Forearm (Only) | Forearms receiving the Placebo | 0 | 22 | 2 | 22 |
| EG002 | Myristyl Forearm (Only) | Forearms receiving the Myristyl | 0 | 22 | 8 | 22 |
| EG003 | Other Non-Derm Events | Systemic Other Adverse Events, i.e. Common Cold, Migraine | 0 | 22 | 1 | 22 |
| Common Cold | Infections and infestations | Systematic Assessment |
|
| Dryness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Flaking | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Flushing | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Migraine | General disorders | Systematic Assessment |
|
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| D006573 |
| Heterocyclic Compounds, 1-Ring |