Pain Control for Laser Epilation in Pilonidal Disease

NCT ID: NCT06640946

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pilonidal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Placebo versus agent crossover per patient
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

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

Group Type PLACEBO_COMPARATOR

Sham cream

Intervention Type DRUG

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

Active agent

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

Group Type ACTIVE_COMPARATOR

Topical lidocaine

Intervention Type DRUG

Topical lidocaine cream prior to laser follicle ablation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Topical lidocaine

Topical lidocaine cream prior to laser follicle ablation

Intervention Type DRUG

Sham cream

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LMX

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

\-
Minimum Eligible Age

16 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

David Mooney

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Mooney

Associate Professor of Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ashley P Stoeckel, MD

Role: STUDY_CHAIR

Boston Children's

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston Children's Hospital at Waltham

Waltham, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P00048869

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pain Perception During Vulvar Biopsy
NCT03654417 TERMINATED PHASE4
Tenaculum Pain Control Study
NCT01421641 COMPLETED PHASE4