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

NCT ID: NCT07273916

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2026-06-30

Brief 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.

Conditions

Pain Management

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention, self-controlled

Self-controlled

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Interventions

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 studied point.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age above 18 years.

2. Willingness and ability to undergo the procedures described in the protocol.

3. Candidates who understand and sign the Informed Consent Form (ICF) upon study entry, prior to any study-related procedures.

Exclusion Criteria

1. Pregnant or breastfeeding on the day of the study.

2. History of sensitivity to topical anesthetics or any component of the anesthetic marker formulation.

3. Symptoms of infection at the application site.

4. Eczema or skin alterations at the application site.

5. Any other active inflammations or infections in the treated areas.

6. Any surgical procedure performed that may have affected the area to be assessed in this study.

7. Severe psychiatric disorders.

8. 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.

9. Use of analgesic medications.

10. 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.

11. Participation in any other clinical drug or device study and/or participation within 7 days prior to Day 1 of this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hexsel Dermatology Clinic

OTHER

Sponsor Role: lead

Responsible Party

Doris Hexsel

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Doris Hexsel, Dr

Role: CONTACT

pesquisa@hexsel.com.br

+5551994840578

Other Identifiers

12-DPCHD-2025-05

Identifier Type: -

Identifier Source: org_study_id