Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00619060
First received: February 19, 2008
Last updated: March 9, 2016
Last verified: September 2014
Results First Received: November 27, 2013  
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
Condition: Healthy
Interventions: Drug: Topical Myristyl Nicotinate Cream
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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

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

Participant Flow:   Overall Study
    Myristyl (Right), Placebo (Left)     Myristyl (Left), Placebo (Right)  
STARTED     10     12  
COMPLETED     10     12  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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


Baseline Measures
    Myristyl, Placebo  
Number of Participants  
[units: participants]
  22  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     19  
>=65 years     3  
Age  
[units: years]
Mean (Standard Deviation)
  50  (12)  
Gender  
[units: participants]
 
Female     10  
Male     12  
Region of Enrollment  
[units: participants]
 
United States     22  



  Outcome Measures

1.  Primary:   Participants With Adverse Events by Treatment.   [ Time Frame: 30 Days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Steve Stratton,PhD Chairman of Scientific Review Comittee
Organization: University of Arizona
phone: (520) 626-9295
e-mail: SStratton@uacc.arizona.edu



Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00619060     History of Changes
Other Study ID Numbers: CDR0000582627
P30CA023074 ( US NIH Grant/Contract Award Number )
UARIZ-BIO-07-085 ( Other Identifier: UA IRB No. )
Study First Received: February 19, 2008
Results First Received: November 27, 2013
Last Updated: March 9, 2016
Health Authority: United States: Food and Drug Administration