Pilot RCT Laser Hair Depilation Darker Skin Pilonidal Disease

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial 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. We 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. We hypothesize that laser hair depilation will lower disease recurrence at 1 year follow-up compared to mechanical/depilation alone (current standard of care). - We 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06406621
Study type	Interventional
Source	Nemours Children's Clinic
Contact	Peter Minneci, MD
Phone	302-333-9549
Email	peter.minneci@nemours.org
Status	Not yet recruiting
Phase	N/A
Start date	March 2025
Completion date	October 2027

View Details

See also
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