Trial Outcomes & Findings for Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers (NCT NCT00619060)
NCT ID: NCT00619060
Last Updated: 2016-03-10
Results Overview
Comparison of number of participants with adverse events by treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
30 Days
Results posted on
2016-03-10
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Myristyl, Placebo
n=22 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 DaysComparison of number of participants with adverse events by treatment.
Outcome measures
| Measure |
Myristyl Nicotinate Cream
n=22 Participants
Participants apply topical myristyl nicotinate to one forearm.
|
Topical Placebo Cream
n=22 Participants
Participants apply topical placebo cream to one forearm.
|
|---|---|---|
|
Participants With Adverse Events by Treatment.
|
8 participants
|
2 participants
|
Adverse Events
Both Forearms
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Forearm (Only)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Myristyl Forearm (Only)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Other Non-Derm Events
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Both Forearms
n=22 participants at risk
Forearms receiving the Myristyl and Placebo, both arms affected
|
Placebo Forearm (Only)
n=22 participants at risk
Forearms receiving the Placebo
|
Myristyl Forearm (Only)
n=22 participants at risk
Forearms receiving the Myristyl
|
Other Non-Derm Events
n=22 participants at risk
Systemic Other Adverse Events, i.e. Common Cold, Migraine
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Burning
|
4.5%
1/22 • Number of events 1 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
4.5%
1/22 • Number of events 2 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
|
Infections and infestations
Common Cold
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
4.5%
1/22 • Number of events 1 • 4 weeks; Baseline to completion
|
|
Skin and subcutaneous tissue disorders
Dryness
|
4.5%
1/22 • Number of events 1 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
18.2%
4/22 • Number of events 4 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
4.5%
1/22 • Number of events 5 • 4 weeks; Baseline to completion
|
22.7%
5/22 • Number of events 7 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
|
Skin and subcutaneous tissue disorders
Flaking
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
4.5%
1/22 • Number of events 2 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
4.5%
1/22 • Number of events 2 • 4 weeks; Baseline to completion
|
9.1%
2/22 • Number of events 6 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
|
Skin and subcutaneous tissue disorders
Irritation
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
9.1%
2/22 • Number of events 2 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
13.6%
3/22 • Number of events 7 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
|
General disorders
Migraine
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
0.00%
0/22 • 4 weeks; Baseline to completion
|
4.5%
1/22 • Number of events 3 • 4 weeks; Baseline to completion
|
Additional Information
Steve Stratton,PhD Chairman of Scientific Review Comittee
University of Arizona
Phone: (520) 626-9295
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place