An Open-Label Safety Study to Evaluate the Use of S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) in Adult Patients Undergoing a Minor or Major Dermal Procedure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 408
- 试验地点
- 5
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in adults. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.
详细描述
The practice of dermatology is seeing a rise in the number of surgical and laser procedures as technological advances have expanded the number of conditions amenable to these evolving therapies. Skin biopsies, shave excisions, deep excisions, electro-surgical procedures, intralesional injections, and laser surgery are frequently performed by dermatologists on a daily basis. Some pain accompanies almost all of these procedures, and a local anesthetic is commonly used. Traditionally, intracutaneous injection of lidocaine (with or without epinephrine) has been the anesthetic of choice. However, patients undergoing these procedures are often afraid of needles and syringes and the pain associated with injections. As a result, topical anesthetic agents have been explored and developed as painless alternatives to injected anesthesia.
S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) consists of a new eutectic formulation of lidocaine and tetracaine. S-Caine Peel is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. S-Caine Peel is not occluded during application.
The purpose of this study is to gain additional safety information for S-Caine Peel when used in minor and major dermal procedures in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18 years of age or older.
- •Patient elects to undergo a minor or major dermal procedure.
- •Patient is able to read and understand a written informed consent and has signed and dated a written informed consent.
排除标准
- •Patient has known allergies, contraindications or sensitivities to lidocaine, tetracaine, or other local anesthetics of the amide or ester type or to any components of the test materials.
- •Patient has known active atopic dermatitis at the designated treatment site.
- •Patient has damaged, denuded or broken skin at the designated treatment site.
- •Patient is pregnant or breastfeeding.
- •Patient has participated in an investigational study or clinical trial of an unapproved drug within the previous 30 days.
- •Patient has enrolled in any previous study involving S-Caine Peel.
研究组 & 干预措施
S-Caine Peel
干预措施: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: 20-30 minutes
To evaluate the safety of a single administration of S-Caine Peel in providing dermal anesthesia over intact skin prior to a minor and major dermal procedure in adults
次要结局
- Adequacy of Anesthesia(20-30 minutes)