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

NCT04523961 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 20-002677
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local; Photodamaged Skin; Topical and Infiltration Anesthetic Toxicity

Outcome Measures

Primary Outcomes (1)

• Self-reported Pain After Laser Treatment

  Participants were asked to rate their pain using the self-reported visual analog scale (VAS). The VAS uses a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 10, with lower scores indicating lower pain and higher scores indicating greater pain.

  After laser treatment, approximately 60 minutes

Secondary Outcomes (2)

• Number of Participants Who Self-reported Itching After Laser Treatment

  After laser treatment, approximately 60 minutes

• Number of Participants Who Self-reported Burning After Laser Treatment

  After laser treatment, approximately 60 minutes

Study Arms (2)

2.5 g of lidocaine 23% / tetracaine 7% ointment

ACTIVE COMPARATOR

Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care will have randomly assigned half of the face applied with 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion for 60 minutes.

Drug: 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion

7.5 g lidocaine 2.5%/ prilocaine 2.5% cream

ACTIVE COMPARATOR

Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care will have randomly assigned half of the face applied with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion for 60 minutes.

Drug: 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion

Interventions

2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion DRUG

Topical anesthetic used to numb the skin prior to laser procedures

Also known as: 23/7 ointment

2.5 g of lidocaine 23% / tetracaine 7% ointment

7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion DRUG

Topical anesthetic used to numb the skin prior to laser procedures

Also known as: EMLA Cream

7.5 g lidocaine 2.5%/ prilocaine 2.5% cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Lidocaine; Tetracaine; Ointments; Salicylic Acid; Prilocaine; Lidocaine, Prilocaine Drug Combination

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Dosage Forms; Pharmaceutical Preparations; Salicylates; Hydroxybenzoates; Hydroxy Acids; Phenols; Drug Combinations

Results Point of Contact

• Title: Elika Hoss, M.D.
• Organization: Mayo Clinic

Hoss.Elika@mayo.edu

480-301-6172

Study Officials

• Elika Hoss

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 24, 2020
• Study Start: January 8, 2021
• Primary Completion: February 19, 2025
• Study Completion: February 19, 2025
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)