Evaluation of Perception of Sting Sensation Following Application of Antibiotic Ointment and Cream Formulations After Tape Stripping Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Saline
0.9% Sodium Chloride Saline Solution (0.3 cc)
干预措施: Saline (Drug)
Isopropyl Alcohol
70% Isopropyl Alcohol (0.3 cc)
干预措施: Isopropyl Alcohol (Drug)
Pain Relieving Cream
Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
干预措施: Pain Relieving Cream (Drug)
Antibiotic/Pain Relieving Ointment
Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
干预措施: Antibiotic/Pain Relieving Ointment (Drug)
Original Ointment
Neosporin® Original Ointment (0.3 cc)
干预措施: Original Ointment (Drug)
Pain Relief Ointment
Neosporin® Plus Pain relief Ointment (0.3 cc)
干预措施: Pain Relief Ointment (Drug)
结局指标
主要结局
Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application
时间窗: 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
时间窗: 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.
次要结局
- Mean Clinician Rating of Overall Wound Condition on Day 8(Day 8)
- Mean Clinician Rating of Overall Wound Condition on Day 1(Day 1)