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

NCT02320695 | Completed Results

• 1 other identifier: CO-140617115421-THCT
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sting

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Mean Clinician Rating of Overall Wound Condition on Day 1

  Day 1

• Mean Clinician Rating of Overall Wound Condition on Day 8

  Day 8

Study Arms (6)

Saline

PLACEBO COMPARATOR

0.9% Sodium Chloride Saline Solution (0.3 cc)

Drug: Saline

Isopropyl Alcohol

PLACEBO COMPARATOR

70% Isopropyl Alcohol (0.3 cc)

Drug: Isopropyl Alcohol

Pain Relieving Cream

EXPERIMENTAL

Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)

Drug: Pain Relieving Cream

Antibiotic/Pain Relieving Ointment

EXPERIMENTAL

Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)

Drug: Antibiotic/Pain Relieving Ointment

Original Ointment

EXPERIMENTAL

Neosporin® Original Ointment (0.3 cc)

Drug: Original Ointment

Pain Relief Ointment

EXPERIMENTAL

Neosporin® Plus Pain relief Ointment (0.3 cc)

Drug: Pain Relief Ointment

Interventions

Saline DRUG

Also known as: Sterile 0.9% Sodium Chloride Saline Solution

Saline

Isopropyl Alcohol DRUG

Also known as: 70 % Isopropyl Alcohol

Isopropyl Alcohol

Pain Relieving Cream DRUG

Also known as: Neosporin® Plus Pain Relieving Cream formula with pH balance technology

Pain Relieving Cream

Antibiotic/Pain Relieving Ointment DRUG

Also known as: Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment

Antibiotic/Pain Relieving Ointment

Original Ointment DRUG

Also known as: Neosporin® Original Ointment

Original Ointment

Pain Relief Ointment DRUG

Also known as: Neosporin® Plus Pain relief Ointment

Pain Relief Ointment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

MeSH Terms

Conditions

Bites and Stings

Interventions

Sodium Chloride; 2-Propanol; bacitracin zinc, neomycin sulfate, polymyxin B, drug combination

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Propanols; Alcohols; Organic Chemicals

Results Point of Contact

• Title: Christopher Nunez, PhD
• Organization: Johnson & Johnson Consumer and Personal Products Worldwide

cnunez1@its.jnj.com

973-385-7984

Study Officials

• Christopher Nunez, PhD

  Johnson & Johnson Consumer and Personal Products Worldwide

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 19, 2014
• Study Start: March 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 5, 2016
• Results First Posted: November 18, 2015

Record last verified: 2015-12