Topical Anesthetic Marker for Pain Reduction in Forearm Tests
This study aims to evaluate how well a topical anesthetic reduces pain in adults during forearm tests by comparing pain levels at different times after application.
Cutaneous marker (Transcutol P+ 20%, Tetracaine 7%, Lidocaine 23%, and dye q.s.),
Agnosia+5
+ Nervous System Diseases
+ Neurologic Manifestations
Prevention Study
Summary
Study start date: March 1, 2026
Actual date on which the first participant was enrolled.This clinical trial aims to test a new topical anesthetic to see how well it can reduce pain caused by a light needle prick on the forearm. The anesthetic contains a mixture of Transcutol P, Tetracaine, Lidocaine, and dye. The study involves 20 participants who will compare the pain relief from the anesthetic against a similar area on the skin where no anesthetic is applied. This is important because finding a quick and effective way to reduce pain can help make medical procedures more comfortable. Participants will have the anesthetic applied to four marked spots on their forearm, which they choose, either left or right. The sensitivity of the skin will be tested every 10 minutes by lightly pricking the area with a needle. The level of pain felt will be measured using a Visual Analog Scale (VAS), which records pain scores 10, 20, 30, and 40 minutes after applying the product. The results will show if the anesthetic reduces pain compared to the untreated area. Safety will also be monitored throughout the study to ensure there are no adverse effects.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives