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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion | Drug | Topical anesthetic used to numb the skin prior to laser procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After laser treatment, approximately 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After laser treatment, approximately 60 minutes |
| Number of Participants Who Self-reported Burning After Laser Treatment |
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Inclusion Criteria:
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:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elika Hoss | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2.5 g of Lidocaine 23% / Tetracaine 7% Ointment | Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care had randomly assigned half of the face applied with 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion for 60 minutes Drug: 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion Topical anesthetic used to numb the skin prior to laser procedures. Other Name: 23/7 ointment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2021 |
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| 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion | Drug | Topical anesthetic used to numb the skin prior to laser procedures |
|
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The number of participants who reported burning sensation after use of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream. |
| After laser treatment, approximately 60 minutes |
| FG001 | 7.5 g Lidocaine 2.5%/ Prilocaine 2.5% Cream | 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. Drug: 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion Topical anesthetic used to numb the skin prior to laser procedures. Other Name: EMLA cream |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 2.5 g of Lidocaine 23% / Tetracaine 7% Ointment and 7.5 g Lidocaine 2.5%/ Prilocaine 2.5% Cream | Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care had randomly assigned half of the face applied with 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion for 60 minutes and the other half of the face applied with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion for 60 minutes. 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion: Topical anesthetic used to numb the skin prior to laser procedures 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion: Topical anesthetic used to numb the skin prior to laser procedures |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | After laser treatment, approximately 60 minutes | Half of Face | Half of Face |
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| Secondary | 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. | Posted | Count of Participants | Participants | After laser treatment, approximately 60 minutes |
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| Secondary | 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. | Posted | Count of Participants | Participants | After laser treatment, approximately 60 minutes |
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Adverse events were collected from the time of informed consent through study completion, approximately 1 day.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2.5 g of Lidocaine 23% / Tetracaine 7% Ointment | Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care had randomly assigned half of the face applied with 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion for 60 minutes Drug: 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion Topical anesthetic used to numb the skin prior to laser procedures. Other Name: 23/7 ointment | 0 | 22 | 0 | 22 | 0 | 22 |
| EG001 | 7.5 g Lidocaine 2.5%/ Prilocaine 2.5% Cream | 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. Drug: 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion Topical anesthetic used to numb the skin prior to laser procedures. Other Name: EMLA cream | 0 | 22 | 0 | 22 | 0 | 22 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elika Hoss, M.D. | Mayo Clinic | 480-301-6172 | Hoss.Elika@mayo.edu |
| Jan 5, 2026 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D013748 | Tetracaine |
| D009824 | Ointments |
| D020156 | Salicylic Acid |
| D011318 | Prilocaine |
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D010636 | Phenols |
| D004338 | Drug Combinations |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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