This Study Will Focus on In-office Dermatological ProceduresPhase 4NCT07724418
Split Face Study of the Duration of Local Anesthetics - Fifth Arm
A Phase 4 study testing Lidocaine HCl/Epinephrine in people with This Study Will Focus on In-office Dermatological Procedures, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- This Study Will Focus on In-office Dermatological Procedures
- What is being tested?
- Lidocaine HCl/Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 May 2027
- Phase
- Phase 4
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Weill Cornell Medicine
New York, New York, 10065
Kira Minkis, MD, PhD, +1 646 962 7948, kim9036@med.cornell.edu
Fengrui Zhan, BS, 6073797248, fez4003@med.cornell.edu
About this study
Official title: Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery
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.
Read the detailed description
This study will compare the relative duration and efficacy of a commonly used local anesthetic (lidocaine with epinephrine) when administered into different layers of the skin on the ventral forearm within the same participant. Specifically, injections will be placed in the intradermal and subcutaneous tissue. A modification of a previously published noninvasive pinprick testing method will be used to assess the duration of local anesthesia. The investigators hypothesize that the duration of anesthesia will differ depending on the depth of injection, with intradermal and subcutaneous administration producing different durations of anesthetic effect.
This study record uses the same protocol document of a previous study under Clinical Trials record NCT06694714, but documents a fifth arm for which data will be analyzed separately from data in NCT06694714.
- Being tested
- Lidocaine HCl/Epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HCl/EpinephrineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intradermal administration of 0.5mL of lidocaine | Experimental | Not described Receives: Drug: Lidocaine HCl/Epinephrine |
| Subcutaneous administration of 0.5mL of lidocaine | Experimental | Not described Receives: Drug: Lidocaine HCl/Epinephrine |
| Intradermal administration of 1.0mL of lidocaine | Experimental | Not described Receives: Drug: Lidocaine HCl/Epinephrine |
| Subcutaneous administration of 1.0mL of lidocaine | Experimental | Not described Receives: Drug: Lidocaine HCl/Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of anesthesia
Time (in minutes) from onset of anesthesia (loss of sharp sensation at the injection site) to return of sharp sensation.
Measured: 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.
Measured: Immediately following injection until loss of sharp sensation, up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study Will Focus on In-office Dermatological ProceduresStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kira Minkis, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724418
- Sponsor's protocol ID
- 22-10025244-2
- Status last verified
- Oct 2026
- First submitted
- 20 Jul 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery
- ClinicalTrials.gov ID
- NCT07724418
- Acronym / sponsor ID
- 22-10025244-2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 24 Jul 2026 (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.
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.
Detailed description
This study will compare the relative duration and efficacy of a commonly used local anesthetic (lidocaine with epinephrine) when administered into different layers of the skin on the ventral forearm within the same participant. Specifically, injections will be placed in the intradermal and subcutaneous tissue. A modification of a previously published noninvasive pinprick testing method will be used to assess the duration of local anesthesia. The investigators hypothesize that the duration of anesthesia will differ depending on the depth of injection, with intradermal and subcutaneous administration producing different durations of anesthetic effect.
This study record uses the same protocol document of a previous study under Clinical Trials record NCT06694714, but documents a fifth arm for which data will be analyzed separately from data in NCT06694714.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Lidocaine HCl/EpinephrineInjection 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. | Drug | 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 |
Primary outcome
Duration of anesthesia
Time frame: From injection until return of sharp sensation, up to 6 hours
Time (in minutes) from onset of anesthesia (loss of sharp sensation at the injection site) to return of sharp sensation.
Onset of anesthesia
Time frame: Immediately following injection until loss of sharp sensation, up to 10 minutes
Duration (in minutes) between anesthetic administration to loss of sensation to sharpness at injection site.
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 29 Oct 2026.
- Individual participant dataSharing planned: No
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.
Kira Minkis, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine HCl/Epinephrine in people with This Study Will Focus on In-office Dermatological Procedures, run by Weill Medical College of Cornell University at 1 site in United States.
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 3 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Kira Minkis, MD, PhD (6469627948, kim9036@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of anesthesia (time frame: From injection until return of sharp sensation, up to 6 hours). The study lists 2 primary outcomes in all. 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 29 Oct 2026.