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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Perception of Sting Sensation Following Application of Antibiotic Ointment and Cream Formulations After Tape Stripping Injury

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 Summary: 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.
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Current Primary Outcome:

  • Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application [ Time Frame: 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 [ Time Frame: 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.


Original Primary Outcome: Subject Sting Assessment [ Time Frame: up to 1 minute ]

The primary endpoint analysis will be the subject assessment of stinging at each test site at the following time points: post-tape stripping, immediately after product application, and approximately 1 minute following product application. The primary endpoint of the assessment of stinging will be assessed via subject reporting of the following:

0 = No stinging sensation

  1. = Mild stinging sensation
  2. = Moderate stinging sensation
  3. = Severe stinging sensation


Current Secondary Outcome:

  • Mean Clinician Rating of Overall Wound Condition on Day 1 [ Time Frame: 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 [ Time Frame: Day 8 ]
    The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.


Original Secondary Outcome:

Information By: Johnson & Johnson Consumer and Personal Products Worldwide

Dates:
Date Received: December 16, 2014
Date Started: March 2015
Date Completion:
Last Updated: December 4, 2015
Last Verified: December 2015