Comparison of Compounded Topical Anesthetics

NCT06569537 | Completed Phase 4 FDA Drug

• 1 other identifier: STUDY02002464
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Procedural Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Left Side BLT

EXPERIMENTAL

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; Drug: BLT

Left Side Lidocaine

EXPERIMENTAL

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; Drug: BLT

Interventions

Lidocaine topical DRUG

4%

Left Side BLT; Left Side Lidocaine

BLT DRUG

Topical Benzocaine 20%/ Lidocaine 8%/Tetracaine 4%

Left Side BLT; Left Side Lidocaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Dermatology Clinic

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Pain, Procedural

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Brian J Simmons, MD

  Dartmouth Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Trials

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: October 22, 2024
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: May 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)