COMPLETED

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

Conditions

Anesthesia, Local Photodamaged Skin Topical and Infiltration Anesthetic Toxicity

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-01-08

Study Completion:2025-02-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04523961

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Principal Investigator

Elika Hoss

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Elika Hoss, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-08

Study Completion Date2025-02-19

Study Record Updates

Study Start Date2021-01-08

Study Completion Date2025-02-19

Terms related to this study

Additional Relevant MeSH Terms

Anesthesia, Local
Photodamaged Skin
Topical and Infiltration Anesthetic Toxicity