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Trial record 11 of 453 for:    applied AND ointment

Trial to Test if Antibiotic Ointments & Cream Will Sting After Application on a Minor Wound After Tape Stripping Injury

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ClinicalTrials.gov Identifier: NCT02320695
Recruitment Status : Completed
First Posted : December 19, 2014
Results First Posted : November 18, 2015
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Sting
Interventions Drug: Saline
Drug: Isopropyl Alcohol
Drug: Pain Relieving Cream
Drug: Antibiotic/Pain Relieving Ointment
Drug: Original Ointment
Drug: Pain Relief Ointment
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OVERALL
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 60
Saline 60
Alcohol 60
Pain Relieving Cream 59
Antibiotic/Pain Relieving Ointment 60
Original Ointment 60
Pain Relief Ointment 60
Completed 60
Not Completed 0
Arm/Group Title OVERALL
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
51.2  (13.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
50
  83.3%
Male
10
  16.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
1.Primary Outcome
Title Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application
Hide Description 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.
Time Frame Post-tape stripping to immediately after investigational product application
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.
Arm/Group Title Saline Isopropyl Alcohol Pain Relieving Cream Antibiotic/Pain Relieving Ointment Original Ointment Pain Relief Ointment
Hide Arm/Group Description:
0.9% Sodium Chloride Saline Solution (0.3 cc)
70% Isopropyl Alcohol (0.3 cc)
Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
Neosporin® Original Ointment (0.3 cc)
Neosporin® Plus Pain relief Ointment (0.3 cc)
Overall Number of Participants Analyzed 34 34 33 34 34 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.29  (0.84) 0.82  (0.94) -0.55  (0.67) -0.65  (0.73) -0.47  (0.61) -0.71  (0.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saline, Pain Relieving Cream
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments For the purpose of showing "equivalent stinging" of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. "Equivalent stinging" of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5.
Statistical Test of Hypothesis P-Value 0.187
Comments [Not Specified]
Method ANCOVA
Comments Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.33 to 0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Saline, Antibiotic/Pain Relieving Ointment
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments For the purpose of showing "equivalent stinging" of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. "Equivalent stinging" of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5.
Statistical Test of Hypothesis P-Value 0.101
Comments [Not Specified]
Method ANCOVA
Comments Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.42 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Saline, Original Ointment
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments For the purpose of showing "equivalent stinging" of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. "Equivalent stinging" of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5.
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.49 to -0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Saline, Pain Relief Ointment
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments For the purpose of showing "equivalent stinging" of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. "Equivalent stinging" of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.53 to -0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application
Hide Description 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.
Time Frame Post-tape stripping to one minute after investigational product application
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.
Arm/Group Title Saline Isopropyl Alcohol Pain Relieving Cream Antibiotic/Pain Relieving Ointment Original Ointment Pain Relief Ointment
Hide Arm/Group Description:
0.9% Sodium Chloride Saline Solution (0.3 cc)
70% Isopropyl Alcohol (0.3 cc)
Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
Neosporin® Original Ointment (0.3 cc)
Neosporin® Plus Pain relief Ointment (0.3 cc)
Overall Number of Participants Analyzed 34 34 33 34 34 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.24  (0.92) -0.35  (0.73) -0.67  (0.65) -0.47  (0.86) -0.50  (0.56) -0.68  (0.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saline, Pain Relieving Cream
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments For the purpose of showing "equivalent stinging" of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. "Equivalent stinging" of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5.
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANCOVA
Comments Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.54 to -0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Saline, Antibiotic/Pain Relieving Ointment
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments For the purpose of showing "equivalent stinging" of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. "Equivalent stinging" of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5.
Statistical Test of Hypothesis P-Value 0.522
Comments [Not Specified]
Method ANCOVA
Comments Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.32 to 0.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Saline, Original Ointment
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments For the purpose of showing "equivalent stinging" of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. "Equivalent stinging" of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.67 to -0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Saline, Pain Relief Ointment
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments For the purpose of showing "equivalent stinging" of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. "Equivalent stinging" of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5.
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method ANCOVA
Comments Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.63 to -0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Clinician Rating of Overall Wound Condition on Day 1
Hide Description The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures.
Arm/Group Title Saline Isopropyl Alcohol Pain Relieving Cream Antibiotic/Pain Relieving Ointment Original Ointment Pain Relief Ointment
Hide Arm/Group Description:
0.9% Sodium Chloride Saline Solution (0.3 cc)
70% Isopropyl Alcohol (0.3 cc)
Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
Neosporin® Original Ointment (0.3 cc)
Neosporin® Plus Pain relief Ointment (0.3 cc)
Overall Number of Participants Analyzed 60 60 59 60 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.42  (1.18) 2.10  (1.02) 2.22  (1.00) 2.50  (1.13) 2.32  (1.23) 2.15  (0.97)
4.Secondary Outcome
Title Mean Clinician Rating of Overall Wound Condition on Day 8
Hide Description The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures.
Arm/Group Title Saline Isopropyl Alcohol Pain Relieving Cream Antibiotic/Pain Relieving Ointment Original Ointment Pain Relief Ointment
Hide Arm/Group Description:
0.9% Sodium Chloride Saline Solution (0.3 cc)
70% Isopropyl Alcohol (0.3 cc)
Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
Neosporin® Original Ointment (0.3 cc)
Neosporin® Plus Pain relief Ointment (0.3 cc)
Overall Number of Participants Analyzed 60 60 59 60 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.43  (0.85) 1.35  (0.68) 1.37  (0.83) 1.35  (0.73) 1.47  (0.89) 1.38  (0.76)
Time Frame Approximately seven days, +30 days for serious adverse events.
Adverse Event Reporting Description Adverse events were systematically collected on Study Day 1 (Visit 1) and approximately seven days later at the end of study visit (Visit 2). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
 
Arm/Group Title OVERALL
Hide Arm/Group Description This includes all 60 randomized subjects.
All-Cause Mortality
OVERALL
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OVERALL
Affected / at Risk (%)
Total   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OVERALL
Affected / at Risk (%)
Total   0/60 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Principal investigator agreed not to publish the study results without prior sponsor approval.
Results Point of Contact
Name/Title: Christopher Nunez, PhD
Organization: Johnson & Johnson Consumer and Personal Products Worldwide
Phone: 973-385-7984
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT02320695     History of Changes
Other Study ID Numbers: CO-140617115421-THCT
First Submitted: December 16, 2014
First Posted: December 19, 2014
Results First Submitted: September 8, 2015
Results First Posted: November 18, 2015
Last Update Posted: January 5, 2016