Comparative Study of Two Topical Anesthetics Prior to Fractional Nonablative Laser Treatment of the Face

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, Local; Photodamaged Skin; Topical and Infiltration Anesthetic Toxicity
• Intervention / Treatment: Drug: 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion; Drug: 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Contact: Elika Hoss, MD; Phone Number: 480-301-6470; Email: hoss.elika@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:
• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 will have 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 Names: 23/7 ointment
Active Comparator: 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 Names: EMLA Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported pain after laser treatment	Measure using a self-reported 11 point (0-10) visual analog scale (VAS) score with higher score indicated greater pain intensity	After laser treatment, approximately 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported itching after laser treatment	Number of participants to report itching sensation after use of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream	After laser treatment, approximately 60 minutes
Self-reported burning after laser treatment	Number of participants to report burning sensation after use of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream	After laser treatment, approximately 60 minutes

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Elika Hoss, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics, Combined; Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination; Tetracaine
• Other Study ID Numbers: 20-002677

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No