Comparison of Compounded Topical Anesthetics

Comparison of Compounded Topical Anesthetics for Pain Relief of Intense Pulsed Light, Pulse Dye Laser, and Microneedling Treatments

The primary objective for this pilot study is to evaluate the efficacy of the compounded topical anesthetic Benzocaine 20%/ Lidocaine 8%/Tetracaine 4% (BLT) compared to 4% Lidocaine topical in providing relief of pain during IPL, PDL, and microneedling procedures.

Study Overview

• Status: Completed
• Conditions: Procedural Pain
• Intervention / Treatment: Drug: Lidocaine topical; Drug: BLT

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth Hitchcock Dermatology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men and women over 18, but not more than 75 years of age.
• Patients who have a regularly scheduled dermatology appointment for Intense Pulse Light (IPL), Pulse Dye Laser (PDL), or microneedling.

Exclusion Criteria:

• Any subject who has a previous history of allergy, sensitivity, and contraindication to benzocaine, lidocaine, or tetracaine.
• Patients with cardiac/respiratory disease, seizure disorder, or neuropathies.
• Patients who are under treatment for a dermatologic condition that may interfere with the evaluation of the study.
• Pregnant women and women who are breastfeeding.
• Patients who report concurrent use of anxiolytics or opiates, which may interfere with the interpretation of results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Left Side BLT; Subjects will receive topical BLT applied to the left side of the face and 4% Lidocaine applied to the right side of the face prior to treatment.	Drug: Lidocaine topical; 4%; Drug: BLT; Topical Benzocaine 20%/ Lidocaine 8%/Tetracaine 4%
Experimental: Left Side Lidocaine; Subjects will receive topical 4% Lidocaine applied to the left side of the face and 4% BLT applied to the right side of the face prior to treatment.	Drug: Lidocaine topical; 4%; Drug: BLT; Topical Benzocaine 20%/ Lidocaine 8%/Tetracaine 4%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain as measured by the Numeric Pain Rating Scale (NPRS)	The NPRS pain scale is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.	At baseline
Pain as measured by the Wong-Baker Face Pain Rating Scale	This scale shows a series of six faces ranging from a happy face at "no hurt" to a crying face at "hurts worst".	At baseline

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Brian J Simmons, MD, Dartmouth Health

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Actual): December 19, 2025
• Study Completion (Actual): December 19, 2025

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Lidocaine
• Other Study ID Numbers: STUDY02002464

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes