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Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00619060
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Healthy
Interventions Drug: Topical Myristyl Nicotinate Cream
Drug: Placebo
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Myristyl (Right), Placebo (Left) Myristyl (Left), Placebo (Right)
Hide Arm/Group Description

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

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
Period Title: Overall Study
Started 10 12
Completed 10 12
Not Completed 0 0
Arm/Group Title Myristyl, Placebo
Hide Arm/Group Description

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

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
  86.4%
>=65 years
3
  13.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
50  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
10
  45.5%
Male
12
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title Participants With Adverse Events by Treatment.
Hide Description Comparison of number of participants with adverse events by treatment.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myristyl Nicotinate Cream Topical Placebo Cream
Hide Arm/Group Description:
Participants apply topical myristyl nicotinate to one forearm.
Participants apply topical placebo cream to one forearm.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
8 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myristyl Nicotinate Cream, Topical Placebo Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Binomial
Comments [Not Specified]
Time Frame 4 weeks; Baseline to completion
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Both Forearms Placebo Forearm (Only) Myristyl Forearm (Only) Other Non-Derm Events
Hide Arm/Group Description Forearms receiving the Myristyl and Placebo, both arms affected Forearms receiving the Placebo Forearms receiving the Myristyl Systemic Other Adverse Events, i.e. Common Cold, Migraine
All-Cause Mortality
Both Forearms Placebo Forearm (Only) Myristyl Forearm (Only) Other Non-Derm Events
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Both Forearms Placebo Forearm (Only) Myristyl Forearm (Only) Other Non-Derm Events
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/22 (0.00%)      0/22 (0.00%)      0/22 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Both Forearms Placebo Forearm (Only) Myristyl Forearm (Only) Other Non-Derm Events
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/22 (4.55%)      2/22 (9.09%)      8/22 (36.36%)      1/22 (4.55%)    
General disorders         
Migraine   0/22 (0.00%)  0 0/22 (0.00%)  0 0/22 (0.00%)  0 1/22 (4.55%)  3
Infections and infestations         
Common Cold   0/22 (0.00%)  0 0/22 (0.00%)  0 0/22 (0.00%)  0 1/22 (4.55%)  1
Skin and subcutaneous tissue disorders         
Burning   1/22 (4.55%)  1 0/22 (0.00%)  0 1/22 (4.55%)  2 0/22 (0.00%)  0
Dryness   1/22 (4.55%)  1 0/22 (0.00%)  0 4/22 (18.18%)  4 0/22 (0.00%)  0
Erythema   0/22 (0.00%)  0 1/22 (4.55%)  5 5/22 (22.73%)  7 0/22 (0.00%)  0
Flaking   0/22 (0.00%)  0 0/22 (0.00%)  0 1/22 (4.55%)  2 0/22 (0.00%)  0
Flushing   0/22 (0.00%)  0 1/22 (4.55%)  2 2/22 (9.09%)  6 0/22 (0.00%)  0
Irritation   0/22 (0.00%)  0 0/22 (0.00%)  0 2/22 (9.09%)  2 0/22 (0.00%)  0
Itching   0/22 (0.00%)  0 0/22 (0.00%)  0 3/22 (13.64%)  7 0/22 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steve Stratton,PhD Chairman of Scientific Review Comittee
Organization: University of Arizona
Phone: (520) 626-9295
EMail: SStratton@uacc.arizona.edu
Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00619060    
Other Study ID Numbers: CDR0000582627
P30CA023074 ( U.S. NIH Grant/Contract )
UARIZ-BIO-07-085 ( Other Identifier: UA IRB No. )
First Submitted: February 19, 2008
First Posted: February 20, 2008
Results First Submitted: November 27, 2013
Results First Posted: March 10, 2016
Last Update Posted: March 10, 2016