Overview

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.