Comparison of Compounded Topical Anesthetics

NCT ID: NCT06569537

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-22

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Procedural Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Lidocaine topical

Intervention Type DRUG

4%

BLT

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Lidocaine topical

Intervention Type DRUG

4%

BLT

Intervention Type DRUG

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

Interventions

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Lidocaine topical

4%

Intervention Type DRUG

BLT

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Brian.J.Simmons

Director of Clinical Trials

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian J Simmons, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth Health

Locations

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Dartmouth Hitchcock Dermatology Clinic

Lebanon, New Hampshire, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nardin Awad, DO

Role: CONTACT

6036532209

Facility Contacts

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Nardin Awad, DO

Role: primary

Other Identifiers

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STUDY02002464

Identifier Type: -

Identifier Source: org_study_id