Evaluation of the Efficacy and Onset of Action of a Topical Anesthetic Marker
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Pain control
研究概览
简要总结
The goal of this clinical trial is to to demonstrate the efficacy of a topical anesthetic in reducing pain during the performance of a painful test on the participant's arm.
Primary Objective:
To evaluate the analgesic efficacy and onset of action of the cutaneous marker (Transcutol P+ 20%, Tetracaine 7%, Lidocaine 23%, and dye q.s.), assessed in comparison with a control area without anesthetic. Pain will be induced by light touches with the same pressure using a disposable needle tip on the forearm region, measured by a visual analog scale (VAS) at 10, 20, 30, and 40 minutes after application of the marker, in a sample of 20 participants.
● Secondary Objective: To assess safety through the recording
- Methodology
After cleansing the skin of the forearm selected by the participant (right or left), four points will be marked and the study product will be applied. Every 10 minutes, sensitivity at the application site and adjacent skin will be tested through superficial pricks performed with the same pressure in the treated area and the adjacent control area. The participant will be asked whether sensitivity is the same in both areas and will be requested to report the percentual reduction in pain at each studied point. 2. Proposed Evaluation Methods Visual Analog Scale (VAS). 3. Visits / Follow-up Duration The test will be conducted on the proposed area (forearm) during a single visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
After cleansing the skin of the forearm selected by the participant (right or left), four points will be marked and the study product will be applied. Every 10 minutes, sensitivity at the application site and adjacent skin will be tested through superficial pricks performed with the same pressure in the treated area and the adjacent control area. The participant will be asked whether sensitivity is the same in both areas and will be requested to report the percentual reduction in pain at each studied point.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age above 18 years.
- •Willingness and ability to undergo the procedures described in the protocol.
- •Candidates who understand and sign the Informed Consent Form (ICF) upon study entry, prior to any study-related procedures.
排除标准
- •Pregnant or breastfeeding on the day of the study.
- •History of sensitivity to topical anesthetics or any component of the anesthetic marker formulation.
- •Symptoms of infection at the application site.
- •Eczema or skin alterations at the application site.
- •Any other active inflammations or infections in the treated areas.
- •Any surgical procedure performed that may have affected the area to be assessed in this study.
- •Severe psychiatric disorders.
- •Any other uncontrolled chronic or serious medical condition which, in the investigator's opinion, may interfere with the interpretation of the clinical study results or place the participant at significant risk.
- •Use of analgesic medications.
- •Vulnerable groups (such as individuals deprived of liberty) as defined in Section 1.61 of the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines.
- •Participation in any other clinical drug or device study and/or participation within 7 days prior to Day 1 of this study.
研究组 & 干预措施
Intervention, self-controlled
Self-controlled
干预措施: Cutaneous marker (Transcutol P+ 20%, Tetracaine 7%, Lidocaine 23%, and dye q.s.), (Drug)
结局指标
主要结局
Pain control
时间窗: 1 day
To evaluate, record, and compare mean Visual Analog Scale (VAS) scores at 10-minute intervals, with time 0 corresponding to product application and the first assessment occurring 10 minutes after application, followed by measurements at 20, 30, and 40 minutes. Assessments will be performed on the left or right forearm according to the participant's preference, using light punctures in the area where the product was applied and comparing results to an adjacent control area.
次要结局
- Time to analgesic effect(1 day)
研究者
Doris Hexsel
Dr
Hexsel Dermatology Clinic