Evaluation of the Efficacy and Onset of Action of a Topical Anesthetic Marker

Обзор

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 1. 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.

Вмешательства

• Препарат Cutaneous marker (Transcutol P+ 20%, Tetracaine 7%, Lidocaine 23%, and dye q.s.),
  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 st

Первичные конечные точки

• Pain control [Срок оценки: 1 day]

Вторичные конечные точки (1)

• Time to analgesic effect [Срок оценки: 1 day]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07273916 · 12-DPCHD-2025-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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