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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHexsel Dermatology Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators