StingNCT02320695

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

A study testing Saline, Isopropyl Alcohol and Pain Relieving Cream in people with Sting, run by Johnson & Johnson Consumer and Personal Products Worldwide.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Sting
What is being tested?: Saline, Isopropyl Alcohol and Pain Relieving Cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: No sites listed yet
Study dates: Mar 2015to Mar 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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

About this study

Official title: 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.

Read the 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.

Conditions: Sting
Being tested: Saline, Isopropyl Alcohol, Pain Relieving Cream, Antibiotic/Pain Relieving Ointment, Original Ointment
Medical subject headings: Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SalineDrug
Also called Sterile 0.9% Sodium Chloride Saline Solution
Isopropyl AlcoholDrug
Also called 70 % Isopropyl Alcohol
Pain Relieving CreamDrug
Also called Neosporin® Plus Pain Relieving Cream formula with pH balance technology
Antibiotic/Pain Relieving OintmentDrug
Also called Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment
Original OintmentDrug
Also called Neosporin® Original Ointment
Pain Relief OintmentDrug
Also called Neosporin® Plus Pain relief Ointment

Study groups in NCT02320695
Study group	Role	What they receive
Saline	Placebo comparator	0.9% Sodium Chloride Saline Solution (0.3 cc) Receives: Drug: Saline
Isopropyl Alcohol	Placebo comparator	70% Isopropyl Alcohol (0.3 cc) Receives: Drug: Isopropyl Alcohol
Pain Relieving Cream	Experimental	Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc) Receives: Drug: Pain Relieving Cream
Antibiotic/Pain Relieving Ointment	Experimental	Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc) Receives: Drug: Antibiotic/Pain Relieving Ointment
Original Ointment	Experimental	Neosporin® Original Ointment (0.3 cc) Receives: Drug: Original Ointment
Pain Relief Ointment	Experimental	Neosporin® Plus Pain relief Ointment (0.3 cc) Receives: Drug: Pain Relief Ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Post-tape stripping to one minute after investigational product application

Secondary outcomes (2)

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.
Measured: 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.
Measured: Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Mar 2015

First posted19 Dec 2014 (estimated)
Study startMar 2015
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for StingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02320695
Sponsor's protocol ID: CO-140617115421-THCT
Status last verified: Dec 2015
First submitted: 16 Dec 2014
Last updated: 5 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Sting trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Perception of Sting Sensation Following Application of Antibiotic Ointment and Cream Formulations After Tape Stripping Injury
ClinicalTrials.gov ID: NCT02320695
Acronym / sponsor ID: CO-140617115421-THCT
Conditions: Sting
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
Study start: Mar 2015
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 19 Dec 2014 (estimated)
Results: Posted 18 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
Saline	Placebo comparator	Drug: Saline0.9% Sodium Chloride Saline Solution (0.3 cc)
Isopropyl Alcohol	Placebo comparator	Drug: Isopropyl Alcohol70% Isopropyl Alcohol (0.3 cc)
Pain Relieving Cream	Experimental	Drug: Pain Relieving CreamNeosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
Antibiotic/Pain Relieving Ointment	Experimental	Drug: Antibiotic/Pain Relieving OintmentNeosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
Original Ointment	Experimental	Drug: Original OintmentNeosporin® Original Ointment (0.3 cc)
Pain Relief Ointment	Experimental	Drug: Pain Relief OintmentNeosporin® Plus Pain relief Ointment (0.3 cc)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SalineAlso: Sterile 0.9% Sodium Chloride Saline Solution	Drug	Saline
Isopropyl AlcoholAlso: 70 % Isopropyl Alcohol	Drug	Isopropyl Alcohol
Pain Relieving CreamAlso: Neosporin® Plus Pain Relieving Cream formula with pH balance technology	Drug	Pain Relieving Cream
Antibiotic/Pain Relieving OintmentAlso: Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment	Drug	Antibiotic/Pain Relieving Ointment
Original OintmentAlso: Neosporin® Original Ointment	Drug	Original Ointment
Pain Relief OintmentAlso: Neosporin® Plus Pain relief Ointment	Drug	Pain Relief Ointment

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.

2 secondary outcomes

Mean Clinician Rating of Overall Wound Condition on Day 1
Time frame: Day 1
Mean Clinician Rating of Overall Wound Condition on Day 8
Time frame: Day 8

Results and safety

Results posted to the registry on 18 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OVERALL	60	60

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. Mean (Standard Deviation). Unit: units on a scale

Measure	Saline n = 34	Isopropyl Alcohol n = 34	Pain Relieving Cream n = 33	Antibiotic/Pain Relieving Ointment n = 34	Original Ointment n = 34	Pain Relief Ointment n = 34
Value	-0.29 (0.84)	0.82 (0.94)	-0.55 (0.67)	-0.65 (0.73)	-0.47 (0.61)	-0.71 (0.58)

Saline vs Pain Relieving Cream: Mean Difference (Net): -0.12 (95% CI -0.33 to 0.05), p = 0.187, ANCOVA
Saline vs Antibiotic/Pain Relieving Ointment: Mean Difference (Net): -0.20 (95% CI -0.42 to 0.04), p = 0.101, ANCOVA
Saline vs Original Ointment: Mean Difference (Net): -0.28 (95% CI -0.49 to -0.10), p = 0.002, ANCOVA

Population analysed: Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.

Primary outcome: 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. Mean (Standard Deviation). Unit: units on a scale

Measure	Saline n = 34	Isopropyl Alcohol n = 34	Pain Relieving Cream n = 33	Antibiotic/Pain Relieving Ointment n = 34	Original Ointment n = 34	Pain Relief Ointment n = 34
Value	-0.24 (0.92)	-0.35 (0.73)	-0.67 (0.65)	-0.47 (0.86)	-0.50 (0.56)	-0.68 (0.64)

Saline vs Pain Relieving Cream: Mean Difference (Net): -0.29 (95% CI -0.54 to -0.05), p = 0.023, ANCOVA
Saline vs Antibiotic/Pain Relieving Ointment: Mean Difference (Net): -0.08 (95% CI -0.32 to 0.20), p = 0.522, ANCOVA
Saline vs Original Ointment: Mean Difference (Net): -0.37 (95% CI -0.67 to -0.16), p <0.001, ANCOVA

Population analysed: Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately seven days, +30 days for serious adverse events.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OVERALL	0 of 60 (0%)	0 of 60 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher Nunez, PhD study director

Johnson & Johnson Consumer and Personal Products Worldwide

Questions about this trial

What is this clinical trial studying?

A study testing Saline, Isopropyl Alcohol and Pain Relieving Cream in people with Sting, run by Johnson & Johnson Consumer and Personal Products Worldwide.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02320695.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.