Comparison of Compounded Topical Anesthetics

Phase 4

Recruiting

• Conditions: Procedural Pain
• Interventions: Drug: Lidocaine topical; Drug: BLT

• Registration Number: NCT06569537
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-23
• Study First Posted: 2024-08-26
• Status Verified: 2024-10
• Study Start: 2024-10-22
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left Side BLT	Lidocaine topical	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.
Left Side Lidocaine	Lidocaine topical	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.
Left Side BLT	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.
Left Side Lidocaine	BLT	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.

Primary Outcome Measures

Name	Time	Method
Pain as measured by the Wong-Baker Face Pain Rating Scale	At baseline	This scale shows a series of six faces ranging from a happy face at "no hurt" to a crying face at "hurts worst".
Pain as measured by the Numeric Pain Rating Scale (NPRS)	At baseline	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.

Trial Locations

Locations (1)

Dartmouth Hitchcock Dermatology Clinic; 🇺🇸 Lebanon, New Hampshire, United States