Recruiting

Laser Hair Depilation

Sponsor:

Nemours Children's Clinic

Code:

NCT06406621

Conditions

Pilonidal Disease

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Not accepted

Interventions

Laser hair depilation

Standard of Care (SOC)

Study Details

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

Study ID

NCT06406621

Start date

Oct 1, 2025

Status verified date

Oct, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Standard Care

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.

experimental: Laser group

Description: Laser hair depiction treatment with Nd:YAG laser every 4-6 weeks until 90% hair reduction is achieved as determined by clinical evaluation. 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.

Interventions

Laser hair depilation

Laser hair depilation treatment with Nd:YAG laser every 4-6 weeks until 90% hair reduction is achieved as determined by clinical evaluation. 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.

Standard of Care (SOC)

The control group will be provided with the "best recommended standard of care" based on recommendations from published studies and guidelines7,31-34 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. Patients and families in the control group will be taught hair removal techniques and the technique of mechanical depilation will be demonstrated for the patient and caregiver with the nurse or physician shaving the gluteal cleft of the patient during this visit. It will be recommended that they perform either chemical (cream application as directed) or mechanical depilation (shaving) as needed to keep the area hair free. The choice between chemical or mechanical depilation is up to the patient and family.

Primary outcome measure

  • Disease Recurrence [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Peter Minneci, MD

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

Lindsey Asti, PhD

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

Locations

Nemours Children's Hospital Delaware

Recruiting

Wilmington, Delaware, United States, 19803

More Information

Sponsor

Nemours Children's Clinic

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Keywords

  • laser hair depilation
  • pilonidal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.