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

Completed · Phase 2/Phase 3

Conditions studied: Anesthesia, Local, Photodamaged Skin, Topical and Infiltration Anesthetic Toxicity

In brief

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.

Key facts

Study ID

NCT04523961

Run by

Mayo Clinic

People needed

22

Starts

2021-01-08

Expected to finish

2025-02-19

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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