Anesthesia, LocalPhase 2/3NCT04523961
Comparative Study of Two Topical Anesthetics Prior to Fractional Nonablative Laser Treatment of the Face
A Phase 2/3 study testing 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion and 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion in people with Anesthesia, Local and Photodamaged Skin, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of lidocaine 2.5%/prilocaine 2.5% cream versus lidocaine 23%/tetracaine 7% ointment for topical anesthesia prior to a nonablative laser procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local, Photodamaged Skin, Topical and Infiltration Anesthetic Toxicity
- What is being tested?
- 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion and 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2021to 19 Feb 2025
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female in general good health.18 years of age or older.
- Undergoing 1927nm fractional thulium laser treatment.
- Fitzpatrick skin type I-IV with at least mild photodamage of the face by physician discretion.
- Subject has completed an appropriately administered informed consent process which includes signing the institutional review board (IRB) approved consent form.
- Willingness to have facial exams and digital photos performed of the face.
- Female patients will be either of non-childbearing potential defined as:
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- Having no uterus;
- No menses for at least 12 months; or
- (WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as:
- Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device;
- Intrauterine coil;
- Bilateral tubal ligation;
- Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom);
- Abstinence (if practicing abstinence must agree to use barrier method described above if becomes sexually active);
- Vasectomized partner (Must agree to use barrier method described above if becomes sexually active with non-vasectomized).
Who cannot join
- Presence of incompletely healed wound or active skin disease within in treatment area.
- Pregnant, planning pregnancy or breastfeeding during the course of the study.
- Individuals who have ablative laser within 6 months; non ablative lasers, facial peels, or dermabrasion within 1 month.
- Individuals with known allergies or sensitivities to any of the ingredients of any topical products being used in this study (a list of the products with active and excipients will be provided below).
- Subjects with any pre-existing medical or psychological condition which, in the opinion of the investigator, would put them at increased risk due to study treatment or participation.
- Subjects who are unable to comprehend the study consent document or provide full written consent.
- Subjects who have taken isotretinoin within 3 months or systemic corticosteroids within 1 month.
- Subjects with history of severe cardiovascular disease, kidney disease, liver disease, uncontrolled diabetes, uncontrolled seizures, immunosuppression.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Double-blinded, Split-face Study Comparing Efficacy of Lidocaine 2.5%/Prilocaine 2.5% Cream Under Occlusion, and Lidocaine 23% /Tetracaine 7% Ointment for Anesthesia Prior to 1927nm Fractional Laser Treatment
The purpose of this study is to determine the efficacy of lidocaine 2.5%/prilocaine 2.5% cream versus lidocaine 23%/tetracaine 7% ointment for topical anesthesia prior to a nonablative laser procedure.
Read the detailed description
Lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream are both topical anesthetics that are used commonly to locally anesthetize the skin prior to laser procedures. With the increased use of powerful lasers for medical and cosmetic purposes, adequate pain control is necessary. This study will compare the efficacy of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream in reducing self-reported pain after laser treatment. It will also aim to determine the amount of redness, burning and itching a patient experiences with each cream, and if any symptoms of lidocaine toxicity are experienced.
Prior to the procedure, we will randomly assign half of the face to be applied with 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion and the other half of the face with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion. After 60 minutes we will remove the creams with soap and water. Next, the patient will be treated with a fractional thulium fiber laser with a fluence of 20 millijoules and treatment level of 7-11. Standard post procedure instructions will be given, and surveys on symptoms and pain will be completed by both patient and investigator.
- Being tested
- 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion, 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusionDrug
Also called 23/7 ointment
Topical anesthetic used to numb the skin prior to laser procedures
7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusionDrug
Also called EMLA Cream
Topical anesthetic used to numb the skin prior to laser procedures
| Study group | Role | What they receive |
|---|---|---|
| 2.5 g of lidocaine 23% / tetracaine 7% ointment | Active comparator | Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care will have randomly assigned half of the face applied with 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion for 60 minutes. Receives: Drug: 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion |
| 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream | Active comparator | Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care will have randomly assigned half of the face applied with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion for 60 minutes. Receives: Drug: 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Pain After Laser Treatment
Participants were asked to rate their pain using the self-reported visual analog scale (VAS). The VAS uses a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 10, with lower scores indicating lower pain and higher scores indicating greater pain.
Measured: After laser treatment, approximately 60 minutes
Secondary outcomes (2)
Number of Participants Who Self-reported Itching After Laser Treatment
The number of participants who reported itching sensation after use of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream.
Measured: After laser treatment, approximately 60 minutes
Number of Participants Who Self-reported Burning After Laser Treatment
The number of participants who reported burning sensation after use of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream.
Measured: After laser treatment, approximately 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start8 Jan 2021
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elika Hoss, MD, Mayo Clinic
- Investigators
- Elika Hoss, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523961
- Sponsor's protocol ID
- 20-002677
- Status last verified
- Feb 2026
- First submitted
- 20 Aug 2020
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blinded, Split-face Study Comparing Efficacy of Lidocaine 2.5%/Prilocaine 2.5% Cream Under Occlusion, and Lidocaine 23% /Tetracaine 7% Ointment for Anesthesia Prior to 1927nm Fractional Laser Treatment
- ClinicalTrials.gov ID
- NCT04523961
- Acronym / sponsor ID
- 20-002677
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 24 Aug 2020 (actual)
- Results
- Posted 20 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy of lidocaine 2.5%/prilocaine 2.5% cream versus lidocaine 23%/tetracaine 7% ointment for topical anesthesia prior to a nonablative laser procedure.
Detailed description
Lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream are both topical anesthetics that are used commonly to locally anesthetize the skin prior to laser procedures. With the increased use of powerful lasers for medical and cosmetic purposes, adequate pain control is necessary. This study will compare the efficacy of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream in reducing self-reported pain after laser treatment. It will also aim to determine the amount of redness, burning and itching a patient experiences with each cream, and if any symptoms of lidocaine toxicity are experienced.
Prior to the procedure, we will randomly assign half of the face to be applied with 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion and the other half of the face with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion. After 60 minutes we will remove the creams with soap and water. Next, the patient will be treated with a fractional thulium fiber laser with a fluence of 20 millijoules and treatment level of 7-11. Standard post procedure instructions will be given, and surveys on symptoms and pain will be completed by both patient and investigator.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2.5 g of lidocaine 23% / tetracaine 7% ointment | Active comparator | Drug: 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusionPatients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care will have randomly assigned half of the face applied with 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion for 60 minutes. |
| 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream | Active comparator | Drug: 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusionPatients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care will have randomly assigned half of the face applied with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion for 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female in general good health.18 years of age or older.
- Undergoing 1927nm fractional thulium laser treatment.
- Fitzpatrick skin type I-IV with at least mild photodamage of the face by physician discretion.
- Subject has completed an appropriately administered informed consent process which includes signing the institutional review board (IRB) approved consent form.
- Willingness to have facial exams and digital photos performed of the face.
Key exclusion criteria (8 listed)
- Presence of incompletely healed wound or active skin disease within in treatment area.
- Pregnant, planning pregnancy or breastfeeding during the course of the study.
- Individuals who have ablative laser within 6 months; non ablative lasers, facial peels, or dermabrasion within 1 month.
- Individuals with known allergies or sensitivities to any of the ingredients of any topical products being used in this study (a list of the products with active and excipients will be provided below).
- Subjects with any pre-existing medical or psychological condition which, in the opinion of the investigator, would put them at increased risk due to study treatment or participation.
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 |
|---|---|---|
| 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusionAlso: 23/7 ointmentTopical anesthetic used to numb the skin prior to laser procedures | Drug | 2.5 g of lidocaine 23% / tetracaine 7% ointment |
| 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusionAlso: EMLA CreamTopical anesthetic used to numb the skin prior to laser procedures | Drug | 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream |
Primary outcome
Self-reported Pain After Laser Treatment
Time frame: After laser treatment, approximately 60 minutes
Participants were asked to rate their pain using the self-reported visual analog scale (VAS). The VAS uses a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 10, with lower scores indicating lower pain and higher scores indicating greater pain.
2 secondary outcomes
Number of Participants Who Self-reported Itching After Laser Treatment
Time frame: After laser treatment, approximately 60 minutes
Number of Participants Who Self-reported Burning After Laser Treatment
Time frame: After laser treatment, approximately 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Elika Hoss principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion and 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion in people with Anesthesia, Local and Photodamaged Skin, run by Mayo Clinic 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 15 inclusion and 8 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: finished, as of the sponsor's last update on 20 Feb 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Pain After Laser Treatment (time frame: After laser treatment, approximately 60 minutes). 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 20 Feb 2026.