NCT04523961

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Anesthesia, Local
• Photodamaged Skin
• Topical and Infiltration Anesthetic Toxicity

Interventions

Type	Name	Description
DRUG	2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion	Topical anesthetic used to numb the skin prior to laser procedures
DRUG	7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion	Topical anesthetic used to numb the skin prior to laser procedures

Timeline

• Start date: 2021-01-08
• Primary completion: 2025-02-19
• Completion: 2025-02-19
• First posted: 2020-08-24
• Last updated: 2026-02-20
• Results posted: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study