Pain ManagementPhase 2NCT07273916
Evaluation of the Efficacy and Onset of Action of a Topical Anesthetic Marker
A Phase 2 study testing Cutaneous marker (Transcutol P+ 20%, Tetracaine 7%, Lidocaine 23%, and dye q.s.), in people with Pain Management, run by Hexsel Dermatology Clinic.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- Cutaneous marker (Transcutol P+ 20%, Tetracaine 7%, Lidocaine 23%, and dye q.s.),
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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.
- Proposed Evaluation Methods Visual Analog Scale (VAS).
- Visits / Follow-up Duration The test will be conducted on the proposed area (forearm) during a single visit.
- Conditions
- Pain Management
- Being tested
- Cutaneous marker (Transcutol P+ 20%, Tetracaine 7%, Lidocaine 23%, and dye q.s.),
- Keywords
- anesthetic, analgesic, pain, control, topical
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutaneous marker (Transcutol P+ 20%, Tetracaine 7%, Lidocaine 23%, and dye q.s.),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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention, self-controlled | Experimental | Self-controlled Receives: Drug: Cutaneous marker (Transcutol P+ 20%, Tetracaine 7%, Lidocaine 23%, and dye q.s.), |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control
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.
Measured: 1 day
Secondary outcomes (1)
Time to analgesic effect
Onset of analgesic effect, defined as the first clinically relevant reduction in VAS pain scores following product application.
● Difference in pain scores between puncture points in the untreated control area and the treated area, assessed at the same time points.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study startMar 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, interventional, self-controlled clinical study.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hexsel Dermatology Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doris Hexsel, Hexsel Dermatology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273916
- Sponsor's protocol ID
- 12-DPCHD-2025-05
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Onset of Action of a Topical Anesthetic Marker
- ClinicalTrials.gov ID
- NCT07273916
- Acronym / sponsor ID
- 12-DPCHD-2025-05
- Conditions
- Pain Management
- Keywords
- anesthetic, analgesic, pain, control, topical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hexsel Dermatology ClinicUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Proposed Evaluation Methods Visual Analog Scale (VAS).
- Visits / Follow-up Duration The test will be conducted on the proposed area (forearm) during a single visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, interventional, self-controlled clinical study.
| Arm | Type | Receives |
|---|---|---|
| Intervention, self-controlled | Experimental | Drug: Cutaneous marker (Transcutol P+ 20%, Tetracaine 7%, Lidocaine 23%, and dye q.s.),Self-controlled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Intervention, self-controlled |
Primary outcome
Pain control
Time frame: 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.
1 secondary outcome
Time to analgesic effect
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
Related trials for Pain Management
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cutaneous marker (Transcutol P+ 20%, Tetracaine 7%, Lidocaine 23%, and dye q.s.), in people with Pain Management, run by Hexsel Dermatology Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doris Hexsel, Dr (+5551994840578, pesquisa@hexsel.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain control (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.