Pilot Trial Assessing the Effectiveness of Laser Hair Depilation on Pilonidal Disease Recurrence in Patients With Darker Skin Color

NCT06406621 | Recruiting

• 2 other identifiers: ITP20243485U54GM104941
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot randomized trial assessing the effectiveness of laser hair depilation on pilonidal disease recurrence in patients with darker skin color

Conditions

Pilonidal Disease

Keywords

laser hair depilation; pilonidal

Outcome Measures

Primary Outcomes (1)

• Disease Recurrence

  Disease recurrence is defined as development of a new pilonidal abscess, folliculitis, or draining sinus after treatment, which would require antibiotic therapy, additional surgical incision and drainage, or excision. development of an abscess, folliculitis, or draining sinus which requires treatment (antibiotic therapy, surgical incision and drainage, or excision).

  1 year

Secondary Outcomes (5)

• Disability days

  1 year

• health-related quality of life (HRQOL) and healthcare satisfaction

  1 year

• Rates of pilonidal disease-related complications

  1 year

• Rates of pilonidal disease-related procedures

  1 year

• Rates of compliance with recommended treatment

  1 year

Study Arms (2)

Standard Care

NO INTERVENTION

Will be provided with the "best recommended standard of care" based on recommendations from published studies and guidelines2,10,13,25,26 including educating on the importance and application of chronic hair removal to provide a standardized education and training to all patients in the control group. They will have the option to schedule additional in-person visits for further education and training on hair removal.

Laser group

EXPERIMENTAL

Description: Laser hair depiction treatment with Nd:YAG laser every 4-6 weeks to obtain a total of 5 treatments. Similar to the control group, they will also receive the "best recommended standard care" including teaching on hair removal techniques and asked to perform either chemical or mechanical depilation as needed between treatments.

Procedure: Laser hair depilation

Interventions

Laser hair depilation PROCEDURE

Laser hair depilation treatment with Nd:YAG laser every 4-6 weeks to obtain a total of 5 treatments. Similar to the control group, they will also receive the "best recommended standard care" including teaching on hair removal techniques and asked to perform either chemical or mechanical depilation as needed between treatments.

Also known as: laser hair removal, laser epilation

Laser group

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 10-21 years
• Diagnosis of pilonidal disease
• Fitzpatrick skin type IV, V, or VI

You may not qualify if:

• History of photosensitivity
• Actively inflamed pilonidal sinus (will be offered enrollment upon resolution).

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Nemours Children's Hospital Delaware

Wilmington, Delaware, 19803, United States

RECRUITING

Study Officials

• Peter C Minneci

  Nemours Children's Health Delaware Valley

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Minneci, MD

CONTACT

302-333-9549; peter.minneci@nemours.org

Lindsey Asti, PhD

CONTACT

302-651-5888; lindsey.asti@nemours.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Surgery

Model Details: Randomization to intervention or control group

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)