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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
Johnson & Johnson Consumer and Personal Products Worldwide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sting

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

    First Posted
    December 16, 2014
    Last Updated
    December 4, 2015
    Sponsor
    Johnson & Johnson Consumer and Personal Products Worldwide
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    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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