Comparison of Compounded Topical Anesthetics

Dartmouth Health

Status and phase: Enrolling; Phase 4

Conditions: Procedural Pain

Treatments: Drug: Lidocaine topical; Drug: BLT

Study type: Interventional

Funder types: Other

Identifiers

NCT06569537

STUDY02002464

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups

Left Side BLT

Experimental group

Description:

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.

Treatment:

Drug: BLT

Drug: Lidocaine topical

Left Side Lidocaine

Experimental group

Description:

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.

Treatment:

Drug: BLT

Drug: Lidocaine topical