Trial to Test if Antibiotic Ointments & Cream Will Sting After Application on a Minor Wound After Tape Stripping Injury
Primary Purpose
Sting
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Saline
Isopropyl Alcohol
Pain Relieving Cream
Antibiotic/Pain Relieving Ointment
Original Ointment
Pain Relief Ointment
Sponsored by
About this trial
This is an interventional treatment trial for Sting
Eligibility Criteria
Inclusion Criteria:
- Males and females, 18-75 years of age, of any race or ethnicity, in generally good health as determined by a medically-qualified individual
- Provide a signed and dated informed consent form prior to start of any study-related procedures
- Able to comprehend and follow the requirements of the study;
- Females of childbearing potential must have a negative urine pregnancy test at the Screening/Baseline visit;
- 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)
- 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:
- Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates)
- Females who are pregnant (positive urine pregnancy test at screening/baseline) or breastfeeding
- Males with a pregnant partner or a partner who is currently trying to become pregnant
- Using steroidal medication (topical or systemic) currently and within 30 days before Visit 1
- Ingestion of systemic anti-histamines or analgesics within the 3 days before Visit 1
- Known sensitivity or allergies to the investigational products, to first aid preparations or local anesthetics (e.g. gauze products, pramoxine), or to adhesive bandages
- Known allergies to unscented soap
- Tendency of forming keloids after wounding
- Tattoos located on the surface of one or both inner (volar) region of forearms
- Heavily pigmented subjects who could heal with abnormal darkening at the test sites on the inner forearms
- Presence of excessive hair on the inner forearms which could interfere with the test procedures
- 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
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Placebo Comparator
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Saline
Isopropyl Alcohol
Pain Relieving Cream
Antibiotic/Pain Relieving Ointment
Original Ointment
Pain Relief Ointment
Arm 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)
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02320695
First Posted
December 16, 2014
Last Updated
December 4, 2015
Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
1. Study Identification
Unique Protocol Identification Number
NCT02320695
Brief Title
Trial to Test if Antibiotic Ointments & Cream Will Sting After Application on a Minor Wound After Tape Stripping Injury
Official Title
Evaluation of Perception of Sting Sensation Following Application of Antibiotic Ointment and Cream Formulations After Tape Stripping Injury
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
0.9% Sodium Chloride Saline Solution (0.3 cc)
Arm Title
Isopropyl Alcohol
Arm Type
Placebo Comparator
Arm Description
70% Isopropyl Alcohol (0.3 cc)
Arm Title
Pain Relieving Cream
Arm Type
Experimental
Arm Description
Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
Arm Title
Antibiotic/Pain Relieving Ointment
Arm Type
Experimental
Arm Description
Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
Arm Title
Original Ointment
Arm Type
Experimental
Arm Description
Neosporin® Original Ointment (0.3 cc)
Arm Title
Pain Relief Ointment
Arm Type
Experimental
Arm Description
Neosporin® Plus Pain relief Ointment (0.3 cc)
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Sterile 0.9% Sodium Chloride Saline Solution
Intervention Type
Drug
Intervention Name(s)
Isopropyl Alcohol
Other Intervention Name(s)
70 % Isopropyl Alcohol
Intervention Type
Drug
Intervention Name(s)
Pain Relieving Cream
Other Intervention Name(s)
Neosporin® Plus Pain Relieving Cream formula with pH balance technology
Intervention Type
Drug
Intervention Name(s)
Antibiotic/Pain Relieving Ointment
Other Intervention Name(s)
Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment
Intervention Type
Drug
Intervention Name(s)
Original Ointment
Other Intervention Name(s)
Neosporin® Original Ointment
Intervention Type
Drug
Intervention Name(s)
Pain Relief Ointment
Other Intervention Name(s)
Neosporin® Plus Pain relief Ointment
Primary Outcome Measure Information:
Title
Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application
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
Title
Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application
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
Secondary Outcome Measure Information:
Title
Mean Clinician Rating of Overall Wound Condition on Day 1
Description
The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.
Time Frame
Day 1
Title
Mean Clinician Rating of Overall Wound Condition on Day 8
Description
The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.
Time Frame
Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and females, 18-75 years of age, of any race or ethnicity, in generally good health as determined by a medically-qualified individual
Provide a signed and dated informed consent form prior to start of any study-related procedures
Able to comprehend and follow the requirements of the study;
Females of childbearing potential must have a negative urine pregnancy test at the Screening/Baseline visit;
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)
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:
Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates)
Females who are pregnant (positive urine pregnancy test at screening/baseline) or breastfeeding
Males with a pregnant partner or a partner who is currently trying to become pregnant
Using steroidal medication (topical or systemic) currently and within 30 days before Visit 1
Ingestion of systemic anti-histamines or analgesics within the 3 days before Visit 1
Known sensitivity or allergies to the investigational products, to first aid preparations or local anesthetics (e.g. gauze products, pramoxine), or to adhesive bandages
Known allergies to unscented soap
Tendency of forming keloids after wounding
Tattoos located on the surface of one or both inner (volar) region of forearms
Heavily pigmented subjects who could heal with abnormal darkening at the test sites on the inner forearms
Presence of excessive hair on the inner forearms which could interfere with the test procedures
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
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Nunez, PhD
Organizational Affiliation
Johnson & Johnson Consumer and Personal Products Worldwide
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Trial to Test if Antibiotic Ointments & Cream Will Sting After Application on a Minor Wound After Tape Stripping Injury
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