Clinical trial NCT04523961: Comparative Study of Two Topical Anesthetics Prior to Fractional Nonablative Laser Treatment of the Face
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Anesthesia, Local
Photodamaged Skin
Topical and Infiltration Anesthetic Toxicity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream are both topical anesthetics that are used commonly to locally anesthetize the skin prior to laser procedures. With the increased use of powerful lasers for medical and cosmetic purposes, adequate pain control is necessary. This study will compare the efficacy of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream in reducing self-reported pain after laser treatment. It will also aim to determine the amount of redness, burning and itching a patient experiences with each cream, and if any symptoms of lidocaine toxicity are experienced.

Prior to the procedure, we will randomly assign half of the face to be applied with 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion and the other half of the face with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion. After 60 minutes we will remove the creams with soap and water. Next, the patient will be treated with a fractional thulium fiber laser with a fluence of 20 millijoules and treatment level of 7-11. Standard post procedure instructions will be given, and surveys on symptoms and pain will be completed by both patient and investigator.

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.

Primary outcomes:
measure: Self-reported pain after laser treatment
timeFrame: After laser treatment, approximately 60 minutes
Secondary outcomes:
measure: Self-reported itching after laser treatment
timeFrame: After laser treatment, approximately 60 minutes
measure: Self-reported burning after laser treatment
timeFrame: After laser treatment, approximately 60 minutes
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Elika Hoss
role: PRINCIPAL_INVESTIGATOR
References: