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

Sting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320695
• Other study ID #: CO-140617115421-THCT
• Status: Completed
• Phase: N/A
• First received: December 16, 2014
• Last updated: December 4, 2015
• Start date: March 2015
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sting

Intervention

Drug:
• Saline

• Isopropyl Alcohol

• Pain Relieving Cream

• Antibiotic/Pain Relieving Ointment

• Original Ointment

• Pain Relief Ointment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer and Personal Products Worldwide

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes