Trial Outcomes & Findings for Comparative Study of Two Topical Anesthetics Prior to Fractional Nonablative Laser Treatment of the Face (NCT NCT04523961)

Last Updated: 2026-02-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

22 participants

Primary outcome timeframe

After laser treatment, approximately 60 minutes

Results posted on

2026-02-20

Participant Flow

Unit of analysis: Half of Face

Participant milestones

Participant milestones
Measure	2.5 g of Lidocaine 23% / Tetracaine 7% Ointment Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care had 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 Topical anesthetic used to numb the skin prior to laser procedures. Other Name: 23/7 ointment	7.5 g Lidocaine 2.5%/ Prilocaine 2.5% Cream 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 Topical anesthetic used to numb the skin prior to laser procedures. Other Name: EMLA cream
Overall Study STARTED	22 22	22 22
Overall Study COMPLETED	22 22	22 22
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2.5 g of Lidocaine 23% / Tetracaine 7% Ointment and 7.5 g Lidocaine 2.5%/ Prilocaine 2.5% Cream n=22 Participants Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care had randomly assigned half of the face applied with 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion for 60 minutes and the other half of the face applied with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion for 60 minutes. 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion: Topical anesthetic used to numb the skin prior to laser procedures 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion: Topical anesthetic used to numb the skin prior to laser procedures
Age, Categorical <=18 years	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=14 Participants
Age, Categorical >=65 years	10 Participants n=14 Participants
Sex: Female, Male Female	17 Participants n=14 Participants
Sex: Female, Male Male	5 Participants n=14 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=14 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=14 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=14 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants
Race (NIH/OMB) Asian	0 Participants n=14 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants
Race (NIH/OMB) Black or African American	0 Participants n=14 Participants
Race (NIH/OMB) White	20 Participants n=14 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=14 Participants
Region of Enrollment United States	22 participants n=14 Participants

PRIMARY outcome

Timeframe: After laser treatment, approximately 60 minutes

Outcome measures

Outcome measures
Measure	2.5 g of Lidocaine 23% / Tetracaine 7% Ointment n=22 Half of Face Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care had 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 Topical anesthetic used to numb the skin prior to laser procedures. Other Name: 23/7 ointment	7.5 g Lidocaine 2.5%/ Prilocaine 2.5% Cream n=22 Half of Face Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care had randomly assigned half of the face applied with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion for 60 minutes. 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion: Topical anesthetic used to numb the skin prior to laser procedures
Self-reported Pain After Laser Treatment	4.5 score on a scale Standard Deviation 1.90	5.0 score on a scale Standard Deviation 2.00

SECONDARY outcome

Timeframe: After laser treatment, approximately 60 minutes

The number of participants who reported itching sensation after use of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream.

Outcome measures

Outcome measures
Measure	2.5 g of Lidocaine 23% / Tetracaine 7% Ointment n=22 Participants Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care had 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 Topical anesthetic used to numb the skin prior to laser procedures. Other Name: 23/7 ointment	7.5 g Lidocaine 2.5%/ Prilocaine 2.5% Cream n=22 Participants Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care had randomly assigned half of the face applied with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion for 60 minutes. 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion: Topical anesthetic used to numb the skin prior to laser procedures
Number of Participants Who Self-reported Itching After Laser Treatment	2 Participants	2 Participants

SECONDARY outcome

Timeframe: After laser treatment, approximately 60 minutes

The number of participants who reported burning sensation after use of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream.

Outcome measures

Outcome measures
Measure	2.5 g of Lidocaine 23% / Tetracaine 7% Ointment n=22 Participants Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care had 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 Topical anesthetic used to numb the skin prior to laser procedures. Other Name: 23/7 ointment	7.5 g Lidocaine 2.5%/ Prilocaine 2.5% Cream n=22 Participants Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care had randomly assigned half of the face applied with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion for 60 minutes. 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion: Topical anesthetic used to numb the skin prior to laser procedures
Number of Participants Who Self-reported Burning After Laser Treatment	9 Participants	7 Participants

Adverse Events

2.5 g of Lidocaine 23% / Tetracaine 7% Ointment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

7.5 g Lidocaine 2.5%/ Prilocaine 2.5% Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elika Hoss, M.D.

Mayo Clinic

Phone: 480-301-6172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place