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

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

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.

Study Overview

• Status: Completed
• Conditions: Sting
• Intervention / Treatment: Drug: Saline; Drug: Isopropyl Alcohol; Drug: Pain Relieving Cream; Drug: Antibiotic/Pain Relieving Ointment; Drug: Original Ointment; Drug: Pain Relief Ointment

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline; 0.9% Sodium Chloride Saline Solution (0.3 cc)	Drug: Saline; Other Names: Sterile 0.9% Sodium Chloride Saline Solution
Placebo Comparator: Isopropyl Alcohol; 70% Isopropyl Alcohol (0.3 cc)	Drug: Isopropyl Alcohol; Other Names: 70 % Isopropyl Alcohol
Experimental: Pain Relieving Cream; Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)	Drug: Pain Relieving Cream; Other Names: Neosporin® Plus Pain Relieving Cream formula with pH balance technology
Experimental: Antibiotic/Pain Relieving Ointment; Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)	Drug: Antibiotic/Pain Relieving Ointment; Other Names: Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment
Experimental: Original Ointment; Neosporin® Original Ointment (0.3 cc)	Drug: Original Ointment; Other Names: Neosporin® Original Ointment
Experimental: Pain Relief Ointment; Neosporin® Plus Pain relief Ointment (0.3 cc)	Drug: Pain Relief Ointment; Other Names: Neosporin® Plus Pain relief Ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.	Day 8

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Investigators: Study Director: Christopher Nunez, PhD, Johnson & Johnson Consumer and Personal Products Worldwide

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: December 18, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Estimate): January 5, 2016
• Last Update Submitted That Met QC Criteria: December 4, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Wounds and Injuries; Poisoning; Bites and Stings; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Enzyme Inhibitors; Protein Synthesis Inhibitors; Antitubercular Agents; Ethanol; Anti-Bacterial Agents; Antibiotics, Antitubercular; Neomycin; Bacitracin; Polymyxin B; Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
• Other Study ID Numbers: CO-140617115421-THCT