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Lidocaine/Tetracaine Ointment vs Lidocaine/Prilocaine Cream for Photoaging

Phase 2 & 3
Recruiting
Led By Elika Hoss
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after laser treatment, approximately 60 minutes
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two topical treatments for numbing skin before a nonablative laser procedure.

Who is the study for?
This trial is for adults in good health with mild to moderate facial photoaging, who are undergoing a specific laser treatment. Women must use birth control if of childbearing potential. Excluded are those with certain skin conditions, severe diseases, recent use of isotretinoin or steroids, allergies to the anesthetics used, and pregnant or breastfeeding women.
What is being tested?
The study compares two topical anesthetics: lidocaine/tetracaine ointment without occlusion versus lidocaine/prilocaine cream with occlusion before nonablative laser procedures on the face. The goal is to see which one is more effective at numbing the skin.
What are the potential side effects?
Potential side effects may include reactions at the application site such as redness, swelling, itching or discomfort; rare systemic effects could be related to absorption like dizziness or irregular heart rate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after laser treatment, approximately 60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and after laser treatment, approximately 60 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Self-reported pain after laser treatment
Secondary study objectives
Self-reported burning after laser treatment
Self-reported itching after laser treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: 2.5 g of lidocaine 23% / tetracaine 7% ointmentActive Control1 Intervention
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.
Group II: 7.5 g lidocaine 2.5%/ prilocaine 2.5% creamActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,357 Previous Clinical Trials
3,062,383 Total Patients Enrolled
Elika HossPrincipal Investigator - Mayo Clinic
Mayo Clinic Arizona
University Of Arizona College Of Medicine (Medical School)

Media Library

2.5 g of lidocaine 23% / tetracaine 7% ointment Clinical Trial Eligibility Overview. Trial Name: NCT04523961 — Phase 2 & 3
Anesthetic Toxicity Research Study Groups: 2.5 g of lidocaine 23% / tetracaine 7% ointment, 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream
Anesthetic Toxicity Clinical Trial 2023: 2.5 g of lidocaine 23% / tetracaine 7% ointment Highlights & Side Effects. Trial Name: NCT04523961 — Phase 2 & 3
2.5 g of lidocaine 23% / tetracaine 7% ointment 2023 Treatment Timeline for Medical Study. Trial Name: NCT04523961 — Phase 2 & 3
~4 spots leftby Jul 2025
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