Split Face Study of the Duration of Local Anesthetics - Fifth Arm

NCT07724418 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 22-10025244-2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare how long local anesthesia lasts when it is injected into different layers of the skin on the forearm. The investigators hypothesize that the numbing effect will last for different amounts of time depending on whether the medication is injected just under the skin or into the skin itself.

Conditions

This Study Will Focus on In-office Dermatological Procedures

Outcome Measures

Primary Outcomes (2)

• Duration of anesthesia

  Time (in minutes) from onset of anesthesia (loss of sharp sensation at the injection site) to return of sharp sensation.

  From injection until return of sharp sensation, up to 6 hours

• Onset of anesthesia

  Duration (in minutes) between anesthetic administration to loss of sensation to sharpness at injection site.

  Immediately following injection until loss of sharp sensation, up to 10 minutes

Study Arms (4)

Intradermal administration of 0.5mL of lidocaine

EXPERIMENTAL

Drug: Lidocaine HCl/Epinephrine

Subcutaneous administration of 0.5mL of lidocaine

EXPERIMENTAL

Drug: Lidocaine HCl/Epinephrine

Intradermal administration of 1.0mL of lidocaine

EXPERIMENTAL

Drug: Lidocaine HCl/Epinephrine

Subcutaneous administration of 1.0mL of lidocaine

EXPERIMENTAL

Drug: Lidocaine HCl/Epinephrine

Interventions

Lidocaine HCl/Epinephrine DRUG

Injection of lidocaine solution for local anesthesia. Participants will receive lidocaine via either intradermal or subcutaneous administration at a volume of 0.5 mL or 1.0 mL.

Intradermal administration of 0.5mL of lidocaine; Intradermal administration of 1.0mL of lidocaine; Subcutaneous administration of 0.5mL of lidocaine; Subcutaneous administration of 1.0mL of lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age
• Normal skin sensation at both nasal ala and volar forearms assessed by pinprick
• Ability to provide informed consent

You may not qualify if:

• Previous adverse reaction to local anesthetic or any components of the local anesthetics being evaluated
• Pregnant or breastfeeding volunteers (assessed by self-report)
• Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Study Officials

• Kira Minkis, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kira Minkis, MD, PhD

CONTACT

6469627948; kim9036@med.cornell.edu

Fengrui Zhan, BS

CONTACT

6073797248; fez4003@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)