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The purpose of this study is to have subjects report whether or not several antibiotic products sting when they are applied to minor wounds created on the inner arms.
The primary objective of this study is to assess the sting potential of single applications of over-the-counter (OTC) topical antibiotic ointments and cream compared to saline (negative control) and isopropyl alcohol (positive control) when applied to a tape-stripped wound site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline | Placebo Comparator | 0.9% Sodium Chloride Saline Solution (0.3 cc) |
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| Isopropyl Alcohol | Placebo Comparator | 70% Isopropyl Alcohol (0.3 cc) |
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| Pain Relieving Cream | Experimental | Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc) |
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| Antibiotic/Pain Relieving Ointment | Experimental | Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc) |
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| Original Ointment | Experimental | Neosporin® Original Ointment (0.3 cc) |
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| Pain Relief Ointment | Experimental | Neosporin® Plus Pain relief Ointment (0.3 cc) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug |
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| |
| Isopropyl Alcohol |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application | 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. | Post-tape stripping to immediately after investigational product application |
| Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application | 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. | Post-tape stripping to one minute after investigational product application |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Clinician Rating of Overall Wound Condition on Day 1 | The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity. | Day 1 |
| Mean Clinician Rating of Overall Wound Condition on Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Nunez, PhD | Johnson & Johnson Consumer and Personal Products Worldwide | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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| Pain Relieving Cream | Drug |
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| Antibiotic/Pain Relieving Ointment | Drug |
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| Original Ointment | Drug |
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| Pain Relief Ointment | Drug |
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The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.
| Day 8 |
| Saline |
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| Alcohol |
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| Pain Relieving Cream |
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| Antibiotic/Pain Relieving Ointment |
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| Original Ointment |
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| Pain Relief Ointment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | OVERALL | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application | 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. | Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol. | Posted | Mean | Standard Deviation | units on a scale | Post-tape stripping to immediately after investigational product application |
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| Primary | Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application | 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. | Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol. | Posted | Mean | Standard Deviation | units on a scale | Post-tape stripping to one minute after investigational product application |
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| Secondary | Mean Clinician Rating of Overall Wound Condition on Day 1 | The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity. | The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures. | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
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| Secondary | Mean Clinician Rating of Overall Wound Condition on Day 8 | The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity. | The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures. | Posted | Mean | Standard Deviation | units on a scale | Day 8 |
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Approximately seven days, +30 days for serious adverse events.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OVERALL | This includes all 60 randomized subjects. | 0 | 60 | 0 | 60 |
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Principal investigator agreed not to publish the study results without prior sponsor approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Nunez, PhD | Johnson & Johnson Consumer and Personal Products Worldwide | 973-385-7984 | cnunez1@its.jnj.com |
| ID | Term |
|---|---|
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D019840 | 2-Propanol |
| C001816 | bacitracin zinc, neomycin sulfate, polymyxin B, drug combination |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D020005 | Propanols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| ANCOVA | Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations. | 0.101 | Mean Difference (Net) | -0.20 | Standard Error of the Mean | 0.12 | 2-Sided | 95 | -0.42 | 0.04 | Yes | Non-Inferiority or Equivalence | 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. |
| ANCOVA | Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations. | 0.002 | Mean Difference (Net) | -0.28 | Standard Error of the Mean | 0.12 | 2-Sided | 95 | -0.49 | -0.10 | Yes | Non-Inferiority or Equivalence | 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. |
| ANCOVA | Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations. | <0.001 | Mean Difference (Net) | -0.31 | Standard Error of the Mean | 0.12 | 2-Sided | 95 | -0.53 | -0.12 | Yes | Non-Inferiority or Equivalence | 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. |
| OG003 | Antibiotic/Pain Relieving Ointment | Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc) |
| OG004 | Original Ointment | Neosporin® Original Ointment (0.3 cc) |
| OG005 | Pain Relief Ointment | Neosporin® Plus Pain relief Ointment (0.3 cc) |
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|
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Neosporin® Original Ointment (0.3 cc) |
| OG005 | Pain Relief Ointment | Neosporin® Plus Pain relief Ointment (0.3 cc) |
|
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Neosporin® Original Ointment (0.3 cc) |
| OG005 | Pain Relief Ointment | Neosporin® Plus Pain relief Ointment (0.3 cc) |
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