Pain Control for Laser Epilation in Pilonidal Disease

NCT06640946 | Completed Phase 4

• 1 other identifier: P00048869
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pilonidal Disease

Outcome Measures

Primary Outcomes (1)

• Pain related to laser follicle ablation

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

  5 minutes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Sham cream placed and then removed prior to laser follicle ablation.

Drug: Sham cream

Active agent

ACTIVE COMPARATOR

Topical lidocaine cream placed and then removed prior to laser follicle ablation.

Drug: Topical lidocaine

Interventions

Topical lidocaine DRUG

Topical lidocaine cream prior to laser follicle ablation

Also known as: LMX

Active agent

Sham cream DRUG

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

Placebo

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• David Mooney: lead

Study Sites (1)

Boston Children's Hospital at Waltham

Waltham, Massachusetts, 02453, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ashley P Stoeckel, MD

  Boston Children's

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Cream will be applied by a clinician not involved in the laser procedure and will be removed prior to the procedure. Laser technicians will assess patient pain and will be blinded, as will the patient, to the study arm.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Surgery

Model Details: Placebo versus agent crossover per patient

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 90 days after study completion, and for 1 year
• Access Criteria: Investigator approval

Locations

US (1)