Pain Control for Laser Epilation in Pilonidal Disease

It's unclear if the application of topical lidocaine prior to laser follicle ablation is effective in reducing discomfort from the procedure. This study will use a doubly blinded case-control model to evaluate pain scores after the procedure comparing topical lidocaine to placebo.

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Key information

Conditions

Pilonidal Disease

Age range

16 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Boston Children's Hospital at Waltham

Waltham, Massachusetts, 02453, United States

About this study

Patients presenting to a dedicated Pilonidal Care Clinic who have at least 2 future laser follicle ablations planned will be queried to determine their interest in participating in the study. Patients will be randomized to topical lidocaine or placebo, which will be applied for 30 minutes prior to the laser procedure, before which it will be removed. Laser technicians will be unaware of which cream the patient received and will record a post-procedure Likert pain score, from 0 to 10.

Patients will return in 6 to 8 weeks at which time they will crossover to the other group. Patients who received lidocaine cream will receive placebo and patients who received placebo will receive lidocaine cream. Cream removal and laser follicle ablation, with post-procedure pain score recording, will be conducted as during the first visit.

Twenty patients will be recruited and each patient will act as their own control.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

undergoing laser follicle ablation for pilonidal disease and expected to need at least 2 more treatments -

Exclusion criteria

Unwilling to consent, not expected to need at least 2 more laser follicle ablations, not a candidate for laser

Treatment and study plan

Topical Lidocaine

Drug

Topical lidocaine cream prior to laser follicle ablation

Other names: LMX

Sham cream

Drug

Placebo cream without lidocaine will be placed and removed before laser.

Primary outcomes

Pain related to laser follicle ablation

Time frame: 5 minutes

Patient description on a Likert scale from 0 to 10 of the discomfort associated with the procedure.

Sponsors and collaborators

Lead sponsor

David Mooney

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 15, 2024
Registry last updated: Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed