Laser Hair Removal for Pilonidal Disease

Overseen By Lindsey Asti, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Disqualifiers: Photosensitivity, Inflamed pilonidal sinus

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 20-30 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether laser hair removal (also known as laser hair depilation) can prevent the recurrence of pilonidal disease, particularly in individuals with darker skin tones. Pilonidal disease involves painful cysts or abscesses near the tailbone, often caused by ingrown hairs. One group of participants will receive laser hair removal treatments, while another group will follow standard care practices, such as learning effective hair removal techniques. The trial seeks individuals aged 10-21 who have been diagnosed with pilonidal disease and have a darker skin tone. As an unphased trial, this study provides a unique opportunity to explore a potentially effective treatment for preventing pilonidal disease recurrence.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that laser hair depilation is safe for pilonidal disease patients with darker skin color?

Research has shown that laser hair removal is safe and effective for individuals with pilonidal disease. Studies have found that patients, including teenagers, tolerate the treatment well. Reports consistently highlight the absence of major issues or side effects associated with this treatment. It is considered a safe option for managing pilonidal disease, especially when used alongside other standard care methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using laser hair removal for pilonidal disease because it offers a novel approach by targeting hair growth directly, which is a key factor in this condition. Traditional treatments often involve surgery or topical hair removal methods, which can be invasive or tedious. The laser treatment uses an Nd:YAG laser, which is designed to provide long-lasting hair reduction, potentially decreasing the need for frequent hair removal sessions and reducing recurrence rates. By addressing the root cause more effectively, this laser technique could offer a more convenient and less invasive solution for patients.

What evidence suggests that laser hair depilation might be an effective treatment for pilonidal disease?

This trial will compare laser hair removal with standard care for pilonidal disease. Studies have shown that laser hair removal can help reduce the recurrence of pilonidal disease. Pilonidal disease occurs when hair becomes trapped under the skin, causing painful cysts or infections. Participants in the laser group will receive laser hair removal along with standard care, which has significantly lowered the chance of recurrence within a year. Research shows that laser treatments reduce the need for additional surgeries or medical procedures. Overall, laser hair removal serves as a useful addition to other treatments for preventing the disease's return. ^{2 5 6 7 8}

Who Is on the Research Team?

Peter C Minneci

Principal Investigator

Nemours Children's Health Delaware Valley

Are You a Good Fit for This Trial?

This trial is for young individuals aged 10-21 with pilonidal disease, which often causes painful cysts near the tailbone. It's specifically aimed at those with darker skin tones, classified as Fitzpatrick skin type IV, V, or VI.

Inclusion Criteria

I am between 10 and 21 years old.

I have been diagnosed with pilonidal disease.

My skin type is dark (Fitzpatrick IV, V, or VI).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive laser hair depilation treatment with Nd:YAG laser every 4-6 weeks for a total of 5 treatments, along with standard care including education on hair removal techniques

20-30 weeks

5 visits (in-person)

Follow-up

Participants are monitored for disease recurrence, disability days, health-related quality of life, healthcare satisfaction, and compliance with treatment over a 1-year period

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Laser Hair Depilation

Trial Overview The study is testing if using laser hair removal can prevent pilonidal disease from coming back in patients with darker skin. Participants are randomly chosen to receive this treatment and then monitored for results.

How Is the Trial Designed?

Group I: Laser group Experimental Treatment 1 Intervention

Description: Laser hair depiction treatment with Nd:YAG laser every 4-6 weeks to obtain a total of 5 treatments. 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.

Group II: Standard Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11260285/

Preventing Pilonidal Sinus Recurrence With Laser Hair Epilation Laser hair epilation offers a way to reduce recurrence rates with reports within the current literature demonstrating positive outcomes compared to alternative ...

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2811756

Laser Epilation as an Adjunct to Standard Care in ... LE as an adjunct to standard care significantly reduced 1-year recurrence rates of pilonidal disease compared with standard care alone.

3. academic.oup.com academic.oup.com/ced/article-abstract/50/6/1132/7958159

Laser hair depilation therapy for pilonidal sinus disease Laser hair depilation is an established adjunct to surgical treatment for PSD. It can lead to reduced rates of recurrence and postsurgical interventions.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S174868150700352X

preventing recurrent pilonidal sinus disease Conclusion. Laser hair depilation is a useful adjunct in preventing the recurrence of pilonidal sinus disease and should be offered routinely to all patients.

5. journals.lww.com journals.lww.com/aosopen/fulltext/2024/09000/heterogeneity_of_treatment_effects_of_laser.36.aspx

Heterogeneity of Treatment Effects of Laser Epilation on... The primary outcome of this study was heterogeneity of treatment effects of laser epilation on pilonidal disease recurrence at 1 year.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29016243/

Safety and Tolerability of Laser Hair Depilation in Pilonidal ... Conclusions: Laser hair depilation is safe and well tolerated in adolescents with pilonidal disease and may be effective at decreasing pilonidal ...

7. liebertpub.com liebertpub.com/doi/10.1089/sur.2017.153?doi=10.1089/sur.2017.153

Safety and Tolerability of Laser Hair Depilation in Pilonidal ... Our study demonstrated that laser hair depilation is safe and well tolerated by adolescents with pilonidal disease. In addition, this study suggests that laser ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06406621

Pilot Trial Assessing the Effectiveness of Laser Hair ... We hypothesize that laser hair depilation will lead to lower rates of disease recurrence at 1-year follow-up compared to standard of care. We will also compare ...