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

Launched by MAYO CLINIC · Aug 20, 2020

Keywords

ClinConnect Summary

This clinical trial is comparing two different creams used to numb the skin before a laser treatment aimed at improving damaged skin on the face. The two creams being tested are lidocaine 2.5%/prilocaine 2.5% and lidocaine 23%/tetracaine 7%. The goal is to find out which cream works better to make the procedure more comfortable for patients.

To participate in this study, you need to be at least 18 years old, in generally good health, and planning to undergo a specific laser treatment called fractional thulium laser. You should have certain skin types with visible sun damage. Women of childbearing age must agree to use effective birth control during the study. Participants will have their faces checked and photographed as part of the study. It's important to note that some individuals, such as those with certain skin conditions, pregnant women, or those with specific medical histories, won't be eligible to join. If you decide to participate, you'll receive clear information and support throughout the process.

Gender

ALL

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.