Trial Outcomes & Findings for Trial to Test if Antibiotic Ointments & Cream Will Sting After Application on a Minor Wound After Tape Stripping Injury (NCT NCT02320695)
NCT ID: NCT02320695
Last Updated: 2016-01-05
Results Overview
The stinging sensation was assessed by the subject using the following scale: 0 = no stinging sensation, 1 = mild stinging sensation, 2 = moderate stinging sensation, and 3 = severe stinging sensation at post-tape stripping and immediately after product application. Change from post-tape striping was calculated as the subject assessment of stinging sensation immediately after investigational product application minus the subject assessment of stinging sensation at post-tape stripping.
COMPLETED
NA
60 participants
Post-tape stripping to immediately after investigational product application
2016-01-05
Participant Flow
Participant milestones
| Measure |
OVERALL
Subjects were assigned to each of the following interventions: Saline, Isopropyl Alcohol, Neosporin Plus Pain Relieving Cream, Neosporin Complete First Aid Antibiotic/Pain Relieving Ointment, Neosporin Original Ointment, Neosporin Plus Pain Relief Ointment. The sequence in which participants received the intervention was randomized.
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|---|---|
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Overall Study
STARTED
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60
|
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Overall Study
Saline
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60
|
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Overall Study
Alcohol
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60
|
|
Overall Study
Pain Relieving Cream
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59
|
|
Overall Study
Antibiotic/Pain Relieving Ointment
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60
|
|
Overall Study
Original Ointment
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60
|
|
Overall Study
Pain Relief Ointment
|
60
|
|
Overall Study
COMPLETED
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60
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial to Test if Antibiotic Ointments & Cream Will Sting After Application on a Minor Wound After Tape Stripping Injury
Baseline characteristics by cohort
| Measure |
OVERALL
n=60 Participants
This includes all 60 randomized subjects. Subjects were assigned to each of the following interventions: Saline, Isopropyl Alcohol, Neosporin Plus Pain Relieving Cream, Neosporin Complete First Aid Antibiotic/Pain Relieving Ointment, Neosporin Original Ointment, Neosporin Plus Pain Relief Ointment. The sequence in which participants received the intervention was randomized.
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|---|---|
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Age, Continuous
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51.2 years
STANDARD_DEVIATION 13.24 • n=39 Participants
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Sex: Female, Male
Female
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50 Participants
n=39 Participants
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Sex: Female, Male
Male
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10 Participants
n=39 Participants
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Region of Enrollment
United States
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60 participants
n=39 Participants
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PRIMARY outcome
Timeframe: Post-tape stripping to immediately after investigational product applicationPopulation: Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.
The stinging sensation was assessed by the subject using the following scale: 0 = no stinging sensation, 1 = mild stinging sensation, 2 = moderate stinging sensation, and 3 = severe stinging sensation at post-tape stripping and immediately after product application. Change from post-tape striping was calculated as the subject assessment of stinging sensation immediately after investigational product application minus the subject assessment of stinging sensation at post-tape stripping.
Outcome measures
| Measure |
Saline
n=34 Participants
0.9% Sodium Chloride Saline Solution (0.3 cc)
|
Isopropyl Alcohol
n=34 Participants
70% Isopropyl Alcohol (0.3 cc)
|
Pain Relieving Cream
n=33 Participants
Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
|
Antibiotic/Pain Relieving Ointment
n=34 Participants
Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
|
Original Ointment
n=34 Participants
Neosporin® Original Ointment (0.3 cc)
|
Pain Relief Ointment
n=34 Participants
Neosporin® Plus Pain relief Ointment (0.3 cc)
|
|---|---|---|---|---|---|---|
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Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application
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-0.29 units on a scale
Standard Deviation 0.84
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0.82 units on a scale
Standard Deviation 0.94
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-0.55 units on a scale
Standard Deviation 0.67
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-0.65 units on a scale
Standard Deviation 0.73
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-0.47 units on a scale
Standard Deviation 0.61
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-0.71 units on a scale
Standard Deviation 0.58
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PRIMARY outcome
Timeframe: Post-tape stripping to one minute after investigational product applicationPopulation: Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.
The stinging sensation was assessed by the subject using the following scale: 0 = no stinging sensation, 1 = mild stinging sensation, 2 = moderate stinging sensation, and 3 = severe stinging sensation at post-tape stripping and one minute after investigational product application. Change from post-tape striping was calculated as the subject assessment of stinging sensation at one minute after investigational product application minus the subject assessment of stinging sensation at post-tape stripping.
Outcome measures
| Measure |
Saline
n=34 Participants
0.9% Sodium Chloride Saline Solution (0.3 cc)
|
Isopropyl Alcohol
n=34 Participants
70% Isopropyl Alcohol (0.3 cc)
|
Pain Relieving Cream
n=33 Participants
Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
|
Antibiotic/Pain Relieving Ointment
n=34 Participants
Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
|
Original Ointment
n=34 Participants
Neosporin® Original Ointment (0.3 cc)
|
Pain Relief Ointment
n=34 Participants
Neosporin® Plus Pain relief Ointment (0.3 cc)
|
|---|---|---|---|---|---|---|
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Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application
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-0.24 units on a scale
Standard Deviation 0.92
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-0.35 units on a scale
Standard Deviation 0.73
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-0.67 units on a scale
Standard Deviation 0.65
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-0.47 units on a scale
Standard Deviation 0.86
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-0.50 units on a scale
Standard Deviation 0.56
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-0.68 units on a scale
Standard Deviation 0.64
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SECONDARY outcome
Timeframe: Day 1Population: The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures.
The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.
Outcome measures
| Measure |
Saline
n=60 Participants
0.9% Sodium Chloride Saline Solution (0.3 cc)
|
Isopropyl Alcohol
n=60 Participants
70% Isopropyl Alcohol (0.3 cc)
|
Pain Relieving Cream
n=59 Participants
Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
|
Antibiotic/Pain Relieving Ointment
n=60 Participants
Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
|
Original Ointment
n=60 Participants
Neosporin® Original Ointment (0.3 cc)
|
Pain Relief Ointment
n=60 Participants
Neosporin® Plus Pain relief Ointment (0.3 cc)
|
|---|---|---|---|---|---|---|
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Mean Clinician Rating of Overall Wound Condition on Day 1
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2.42 units on a scale
Standard Deviation 1.18
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2.10 units on a scale
Standard Deviation 1.02
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2.22 units on a scale
Standard Deviation 1.00
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2.50 units on a scale
Standard Deviation 1.13
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2.32 units on a scale
Standard Deviation 1.23
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2.15 units on a scale
Standard Deviation 0.97
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SECONDARY outcome
Timeframe: Day 8Population: The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures.
The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.
Outcome measures
| Measure |
Saline
n=60 Participants
0.9% Sodium Chloride Saline Solution (0.3 cc)
|
Isopropyl Alcohol
n=60 Participants
70% Isopropyl Alcohol (0.3 cc)
|
Pain Relieving Cream
n=59 Participants
Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
|
Antibiotic/Pain Relieving Ointment
n=60 Participants
Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
|
Original Ointment
n=60 Participants
Neosporin® Original Ointment (0.3 cc)
|
Pain Relief Ointment
n=60 Participants
Neosporin® Plus Pain relief Ointment (0.3 cc)
|
|---|---|---|---|---|---|---|
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Mean Clinician Rating of Overall Wound Condition on Day 8
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1.43 units on a scale
Standard Deviation 0.85
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1.35 units on a scale
Standard Deviation 0.68
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1.37 units on a scale
Standard Deviation 0.83
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1.35 units on a scale
Standard Deviation 0.73
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1.47 units on a scale
Standard Deviation 0.89
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1.38 units on a scale
Standard Deviation 0.76
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Adverse Events
OVERALL
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Christopher Nunez, PhD
Johnson & Johnson Consumer and Personal Products Worldwide
Results disclosure agreements
- Principal investigator is a sponsor employee Principal investigator agreed not to publish the study results without prior sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER