Comparing two topical anesthetics for laser treatment pain relief

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

This study is testing which of two creams can better reduce pain during laser treatment on the face for people getting this procedure.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (other)
• Locations: 1 site (Scottsdale, Arizona)
• Trial ID: NCT04523961 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of two topical anesthetics, lidocaine 2.5%/prilocaine 2.5% cream and lidocaine 23%/tetracaine 7% ointment, in reducing pain during fractional nonablative laser treatment of the face. Participants will have one side of their face treated with each anesthetic, and their pain levels, as well as any side effects like redness or itching, will be assessed after the procedure. The goal is to determine which anesthetic provides better pain control and fewer adverse effects during laser treatment.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 and older with Fitzpatrick skin types I-IV and mild facial photodamage who are scheduled for fractional thulium laser treatment.

Not a fit: Patients with severe skin conditions, those not undergoing the specified laser treatment, or individuals with contraindications to the anesthetics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management options for patients undergoing laser treatments.

How similar studies have performed: Previous studies have shown varying success with topical anesthetics in similar settings, but this specific comparison is novel.

Eligibility criteria

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.

Where this trial is running

Scottsdale, Arizona

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States (RECRUITING)

Study contacts

• Principal investigator: Elika Hoss — Mayo Clinic

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