Actively Recruiting
Pilot Trial Assessing the Effectiveness of Laser Hair Depilation on Pilonidal Disease Recurrence in Patients With Darker Skin Color
Led by Nemours Children's Clinic · Updated on 2025-10-24
36
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
N
Nemours Children's Clinic
Lead Sponsor
N
National Institute of General Medical Sciences (NIGMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of laser hair depilation in reducing the recurrence of pilonidal disease among patients with darker skin types. Pilonidal disease is a painful infection near the tailbone that often recurs despite treatments like hair removal, hygiene, antibiotics, and drainage. This pilot randomized trial aims to compare laser hair depilation combined with standard care to standard care alone, focusing on patients aged 10 to 21 with darker skin tones to promote equitable treatment options. Participants will be randomly assigned to one of two groups. The intervention group will receive laser hair depilation treatments using an Nd:YAG laser every 4 to 6 weeks for a total of five sessions, alongside education on hair removal techniques. The control group will receive the best recommended standard care, including education on chronic hair removal and the option for additional training and support. Both groups will be asked to perform chemical or mechanical hair removal as needed. During the year-long study, participants will be monitored for pilonidal disease recurrence, disability days, quality of life, healthcare satisfaction, complications, and treatment compliance. Researchers will assess these outcomes at one year to understand the impact of laser hair depilation on disease recurrence and related morbidity. This exploratory pilot will help design a larger study to confirm the benefits and promote inclusive care for underrepresented populations with darker skin types.
CONDITIONS
Brief Title
Pilot Trial Assessing the Effectiveness of Laser Hair Depilation on Pilonidal Disease Recurrence in Patients With Darker Skin Color
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 10 and 21 years
- Diagnosis of pilonidal disease
- Fitzpatrick skin type IV, V, or VI
You will not qualify if you...
- History of photosensitivity
- Actively inflamed pilonidal sinus (enrollment possible after resolution)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 20 to 30 weeks
Participants receive laser hair depilation treatments every 4 to 6 weeks for a total of 5 treatments or receive standard care with education on hair removal techniques. Both groups are asked to perform chemical or mechanical hair depilation as needed between treatments.
5 visits (in-person) for laser treatments; additional visits possible for education in the standard care group
Duration - Up to 1 year from treatment start
Participants are monitored for pilonidal disease recurrence, disability, quality of life, complications, procedures, and treatment compliance up to 1 year after treatment begins.
Periodic follow-up visits up to 1 year
Trial Site Locations
Total: 1 location
1
Nemours Children's Hospital Delaware
Wilmington, Delaware, United States, 19803
Actively Recruiting
Research Team
P
Peter Minneci, MD
L
Lindsey Asti, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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