Pain Control for Laser Epilation in Pilonidal Disease

Phase 4

Not yet recruiting

• Conditions: Pilonidal Disease
• Interventions: Drug: Sham cream; Drug: Topical lidocaine

• Registration Number: NCT06640946
• Lead Sponsor: David Mooney

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-16
• Study Start: 2024-11-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Sham cream	Sham cream placed and then removed prior to laser follicle ablation.
Active agent	Topical lidocaine	Topical lidocaine cream placed and then removed prior to laser follicle ablation.

Primary Outcome Measures

Name	Time	Method
Pain related to laser follicle ablation	5 minutes	Patient description on a Likert scale from 0 to 10 of the discomfort associated with the procedure.