Laser Hair Depilation Darker Skin Pilonidal Disease

Pilonidal Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06406621
• Other study ID #: ITP20243485
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2025
• Est. completion date: October 2027

Study information

• Verified date: June 2024
• Source: Nemours Children's Clinic
• Contact: Peter Minneci, MD
• Phone: 302-333-9549
• Email: peter.minneci[@]nemours.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Focused study on laser hair depilation in patients with darker skin types is critical to promote equitable health care across all patients with pilonidal disease. The investigators propose a pilot RCT of laser hair depilation to the gluteal cleft in darker skin adolescents and young adults with pilonidal disease to estimate the efficacy of laser hair depilation to decrease disease recurrence compared with standard of care. This study will enroll patients with Fitzpatrick skin types IV-VI to be inclusive of both Hispanic and Non-Hispanic Black populations to allow us to investigate efficacy of this treatment across ethnic and racial groups and skin type.

Specific Aim 1: To determine the efficacy of laser hair depilation to prevent recurrence of pilonidal disease at 1 year among patients with Fitzpatrick skin types of IV-VI. The investigators hypothesize that laser hair depilation will lower disease recurrence at 1 year follow-up compared to mechanical/depilation alone (current standard of care).

• The investigators will perform an RCT comparing laser hair depilation with mechanical/chemical depilation (intervention group) to mechanical/chemical depilation alone (control group).

• Primary outcome: Disease recurrence at 1 year defined as development of an abscess, folliculitis, or draining sinus which requires treatment (antibiotic therapy, surgical incision and drainage, or excision).

Specific Aim 2: To investigate the efficacy of laser hair depilation to reduce pilonidal-related morbidity, improve healthcare satisfaction, and increase health-related quality of life (HRQOL) among patients with Fitzpatrick skin types IV-VI. We hypothesize that laser hair depilation will reduce disability, improve healthcare satisfaction, increase HRQOL, and lead to fewer procedures.

• Disability days, defined as the number of reported days in which the patient was not able to participate in all activities or work, will be calculated at 1 year and compared between the two groups.

• Patient satisfaction with care and HRQOL will be measured with validated PedsQLTM instruments.

• Procedures, admissions, emergency department visits, and complications will be compared.

This pilot study will generate the efficacy estimates needed to design a multicenter RCT to provide definitive evidence to support equitable inclusion of laser hair depilation as a treatment adjunct for pilonidal disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: October 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fistula
• Pilonidal Abscess
• Pilonidal Cyst/Fistula
• Pilonidal Disease
• Pilonidal Sinus

Intervention

Procedure:
• Laser hair depilation
1 treatment every 4-6 weeks to obtain a total of 5 treatments. The laser treatment group will consist of an Nd:YAG application to teh gluteal cleft

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Recurrence	development of an abscess, folliculitis, or draining sinus which requires treatment (antibiotic therapy, 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	health-related quality of life (HRQOL)	health-related quality of life (HRQOL) as measured using PedsQL instrument	1 year
Secondary	healthcare satisfaction	healthcare satisfaction as measured using PedsQL instrument	1 year
Secondary	Disability days	Disability days, defined as the number of reported days in which the patient was not able to participate in all activities or work	1 year