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

Summary

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.

Timeline

Start

2026-03

Primary completion

2026-05

Completion

2026-06

Drugs

Indications

No indication recorded.