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Trial record 53 of 61 for:    Neomycin sulfate

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

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ClinicalTrials.gov Identifier: NCT02320695
Recruitment Status : Completed
First Posted : December 19, 2014
Results First Posted : November 18, 2015
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

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.

Condition or disease Intervention/treatment Phase
Sting Drug: Saline Drug: Isopropyl Alcohol Drug: Pain Relieving Cream Drug: Antibiotic/Pain Relieving Ointment Drug: Original Ointment Drug: Pain Relief Ointment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Perception of Sting Sensation Following Application of Antibiotic Ointment and Cream Formulations After Tape Stripping Injury
Study Start Date : March 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Saline
0.9% Sodium Chloride Saline Solution (0.3 cc)
Drug: Saline
Other Name: Sterile 0.9% Sodium Chloride Saline Solution

Placebo Comparator: Isopropyl Alcohol
70% Isopropyl Alcohol (0.3 cc)
Drug: Isopropyl Alcohol
Other Name: 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 Name: 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 Name: Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment

Experimental: Original Ointment
Neosporin® Original Ointment (0.3 cc)
Drug: Original Ointment
Other Name: Neosporin® Original Ointment

Experimental: Pain Relief Ointment
Neosporin® Plus Pain relief Ointment (0.3 cc)
Drug: Pain Relief Ointment
Other Name: Neosporin® Plus Pain relief Ointment




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320695


Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
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Study Director: Christopher Nunez, PhD Johnson & Johnson Consumer and Personal Products Worldwide

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Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT02320695     History of Changes
Other Study ID Numbers: CO-140617115421-THCT
First Posted: December 19, 2014    Key Record Dates
Results First Posted: November 18, 2015
Last Update Posted: January 5, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
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Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Neomycin
Bites and Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries
Ethanol
Bacitracin
Pramoxine
Polymyxin B
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents