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

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Lidocaine; Lidocaine, Prilocaine Drug Combination; Prilocaine; Tetracaine

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.