Sting
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGSaline
DRUGPain Relieving Cream
DRUGAntibiotic/Pain Relieving Ointment
DRUGOriginal Ointment
DRUGPain Relief Ointment
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females, 18-75 years of age, of any race or ethnicity, in generally good health as determined by a medically-qualified individual 2. Provide a signed and dated informed consent form prior to start of any study-related procedures 3. Able to comprehend and follow the requirements of the study; 4. Females of childbearing potential must have a negative urine pregnancy test at the Screening/Baseline visit; 5. Male or non-pregnant, non-lactating females agree to the contraceptive requirements (including female partner's use of a highly effective form of birth control. Females must have used the same birth control for 1 month before Screening and continue to use it through 1 month after administration of study drug) 6. Willing and able to comply with the tape stripping and all study procedures and attend the scheduled visits for the duration of the study
Exclusion criteria
1. Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates) 2. Females who are pregnant (positive urine pregnancy test at screening/baseline) or breastfeeding 3. Males with a pregnant partner or a partner who is currently trying to become pregnant 4. Using steroidal medication (topical or systemic) currently and within 30 days before Visit 1 5. Ingestion of systemic anti-histamines or analgesics within the 3 days before Visit 1 6. Known sensitivity or allergies to the investigational products, to first aid preparations or local anesthetics (e.g. gauze products, pramoxine), or to adhesive bandages 7. Known allergies to unscented soap 8. Tendency of forming keloids after wounding 9. Tattoos located on the surface of one or both inner (volar) region of forearms 10. Heavily pigmented subjects who could heal with abnormal darkening at the test sites on the inner forearms 11. Presence of excessive hair on the inner forearms which could interfere with the test procedures 12. Presents with skin disorders on the inner arms (cuts, scratches, scars, etc), which in the opinion of the Investigator or qualified designee, will interfere with the study assessment or will create undue risk for the subject 13. Pre-existing or dormant dermatologic skin conditions (e.g., eczema, seborrheic dermatitis, atopic dermatitis, psoriasis, vitiligo, etc.) that could interfere with the outcome of the study as determined by the Investigator or qualified designee 14. Other medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application | Post-tape stripping to 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. |
| Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application | Post-tape stripping to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Clinician Rating of Overall Wound Condition on Day 1 | Day 1 | The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity. |
| Mean Clinician Rating of Overall Wound Condition on Day 8 | Day 8 | The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | OVERALL |
|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 13.24 |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
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.
Time frame: Post-tape stripping to immediately after investigational product application
Population: Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saline | Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application | -0.29 units on a scale | Standard Deviation 0.84 |
| Isopropyl Alcohol | Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application | 0.82 units on a scale | Standard Deviation 0.94 |
| Pain Relieving Cream | Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application | -0.55 units on a scale | Standard Deviation 0.67 |
| Antibiotic/Pain Relieving Ointment | Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application | -0.65 units on a scale | Standard Deviation 0.73 |
| Original Ointment | Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application | -0.47 units on a scale | Standard Deviation 0.61 |
| Pain Relief Ointment | Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application | -0.71 units on a scale | Standard Deviation 0.58 |
p-value: 0.00295% CI: [-0.49, -0.1]ANCOVA
p-value: <0.00195% CI: [-0.53, -0.12]ANCOVA
p-value: 0.18795% CI: [-0.33, 0.05]ANCOVA
p-value: 0.10195% CI: [-0.42, 0.04]ANCOVA
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.
Time frame: Post-tape stripping to one minute after investigational product application
Population: Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saline | Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application | -0.24 units on a scale | Standard Deviation 0.92 |
| Isopropyl Alcohol | Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application | -0.35 units on a scale | Standard Deviation 0.73 |
| Pain Relieving Cream | Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application | -0.67 units on a scale | Standard Deviation 0.65 |
| Antibiotic/Pain Relieving Ointment | Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application | -0.47 units on a scale | Standard Deviation 0.86 |
| Original Ointment | Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application | -0.50 units on a scale | Standard Deviation 0.56 |
| Pain Relief Ointment | Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application | -0.68 units on a scale | Standard Deviation 0.64 |
p-value: 0.02395% CI: [-0.54, -0.05]ANCOVA
p-value: 0.52295% CI: [-0.32, 0.2]ANCOVA
p-value: <0.00195% CI: [-0.67, -0.16]ANCOVA
p-value: 0.01395% CI: [-0.63, -0.07]ANCOVA
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.
Time frame: Day 1
Population: The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saline | Mean Clinician Rating of Overall Wound Condition on Day 1 | 2.42 units on a scale | Standard Deviation 1.18 |
| Isopropyl Alcohol | Mean Clinician Rating of Overall Wound Condition on Day 1 | 2.10 units on a scale | Standard Deviation 1.02 |
| Pain Relieving Cream | Mean Clinician Rating of Overall Wound Condition on Day 1 | 2.22 units on a scale | Standard Deviation 1 |
| Antibiotic/Pain Relieving Ointment | Mean Clinician Rating of Overall Wound Condition on Day 1 | 2.50 units on a scale | Standard Deviation 1.13 |
| Original Ointment | Mean Clinician Rating of Overall Wound Condition on Day 1 | 2.32 units on a scale | Standard Deviation 1.23 |
| Pain Relief Ointment | Mean Clinician Rating of Overall Wound Condition on Day 1 | 2.15 units on a scale | Standard Deviation 0.97 |
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.
Time frame: Day 8
Population: The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saline | Mean Clinician Rating of Overall Wound Condition on Day 8 | 1.43 units on a scale | Standard Deviation 0.85 |
| Isopropyl Alcohol | Mean Clinician Rating of Overall Wound Condition on Day 8 | 1.35 units on a scale | Standard Deviation 0.68 |
| Pain Relieving Cream | Mean Clinician Rating of Overall Wound Condition on Day 8 | 1.37 units on a scale | Standard Deviation 0.83 |
| Antibiotic/Pain Relieving Ointment | Mean Clinician Rating of Overall Wound Condition on Day 8 | 1.35 units on a scale | Standard Deviation 0.73 |
| Original Ointment | Mean Clinician Rating of Overall Wound Condition on Day 8 | 1.47 units on a scale | Standard Deviation 0.89 |
| Pain Relief Ointment | Mean Clinician Rating of Overall Wound Condition on Day 8 | 1.38 units on a scale | Standard Deviation 0.76 |