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Trial Title:
Pilot Trial Assessing the Effectiveness of Laser Hair Depilation on Pilonidal Disease Recurrence in Patients With Darker Skin Color
NCT ID:
NCT06406621
Condition:
Pilonidal Disease
Pilonidal Sinus
Pilonidal Abscess
Pilonidal Cyst/Fistula
Conditions: Official terms:
Pilonidal Sinus
Recurrence
Fistula
Conditions: Keywords:
laser hair depilation
pilonidal
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomization to intervention or control group
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Laser hair depilation
Description:
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
Arm group label:
Laser group
Other name:
laser hair removal
Other name:
laser epilation
Summary:
Pilot randomized trial assessing the effectiveness of laser hair depilation on pilonidal
disease recurrence in patients with darker skin color
Detailed 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.
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
10 Years
Maximum age:
21 Years
Healthy volunteers:
No
Start date:
January 1, 2025
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Nemours Children's Clinic
Agency class:
Other
Source:
Nemours Children's Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06406621
