NCT06640946

Pain Control for Laser Epilation in Pilonidal Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: David Mooney · Academic / Other
• Sex: All
• Age: 16 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pilonidal Disease

Interventions

Type	Name	Description
DRUG	Topical lidocaine	Topical lidocaine cream prior to laser follicle ablation
DRUG	Sham cream	Placebo cream without lidocaine will be placed and removed before laser.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2024-10-15
• Last updated: 2025-06-18

Locations

1 site across 1 country: United States