Pilonidal DiseaseNCT06406621
Pilot Trial Assessing the Effectiveness of Laser Hair Depilation on Pilonidal Disease Recurrence in Patients With Darker Skin Color
A study testing Laser hair depilation in people with Pilonidal Disease, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
Pilot randomized trial assessing the effectiveness of laser hair depilation on pilonidal disease recurrence in patients with darker skin color Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Pilonidal Disease
- What is being tested?
- Laser hair depilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 10-21 years
- Diagnosis of pilonidal disease
- Fitzpatrick skin type IV, V, or VI
Who cannot join
- History of photosensitivity
- Actively inflamed pilonidal sinus (will be offered enrollment upon resolution).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nemours Children's Hospital Delaware
Wilmington, Delaware, 19803
Peter Minneci
About this study
Pilot randomized trial assessing the effectiveness of laser hair depilation on pilonidal disease recurrence in patients with darker skin color
Read the detailed description
Pilonidal disease is a painful skin infection that occurs in the crease of the buttocks near the tailbone (gluteal cleft) and affects approximately 1% of the population between the ages of 15-30 years. Medical therapy of pilonidal disease is largely dependent upon continued hair removal, meticulous hygiene to the area, and recurrent courses of antibiotics with intermittent incision and drainage procedures. However, recurrent pilonidal disease after initial incision and drainage can be as high as 40% and wound complications after resection have been reported to be as high as 30%. Recurrence often leads to a substantial burden on patients with dependence on caregivers, long term disability, reduced quality of life, and social withdrawal.
Chronic hair removal to the gluteal cleft is a consistently recommended therapy to prevent pilonidal disease recurrence. Research has demonstrated the efficacy of laser hair depilation of the gluteal cleft to reduce pilonidal disease recurrence compared to standard of care in adult and adolescents. A recent randomized controlled trial (RCT) demonstrated laser hair depilation significantly decreased recurrence rates at 1 year from 33% to 10%. However, in exploratory secondary analyses, there was potential heterogeneity of treatment effect based on self-reported race and ethnicity. Although limited by small numbers of patients in many of the racial and ethnic groups, there was a significant reduction in disease recurrence among Non-Hispanic White patients with laser treatment but no change in recurrence among all other groups.
This study will investigate the effects of laser hair depilation on pilonidal disease recurrence among those with darker skin types. We will perform a pilot RCT comparing laser hair depilation and mechanical/chemical depilation (intervention group) to mechanical/chemical depilation alone (control group). The rate of recurrence of pilonidal disease at 1 year will be compared between the two groups. 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. 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 differences in the 1-year morbidity associated with pilonidal disease between the two groups. We hypothesize that laser hair depilation will lead to less morbidity including less disability, higher health related quality of life, higher healthcare satisfaction, and fewer procedures, surgical excisions, and post-operative complications.
This is an exploratory pilot trial aimed at generating an effect size to inform the design of a larger confirmatory study with formal hypothesis testing. The recurrence rate within 1 year is expected to be 30% in the control group, while it is unknown in the laser group, with an expectation of a substantially lower rate in this group. A sample size of 30 patients (15 in each group) can detect an absolute reduction of 29% in the recurrence rate in the laser group compared to the control group, with a power of 80% at a significance level of 0.05. However, we anticipate a minimum reduction of 10% in the recurrence rate in the laser group. The planned sample size of 30 patients will yield a two-sided 95% confidence interval with a precision of 0.31 (half-width) to estimate this difference when the recurrence rate is 30% in the control group and 20% in the laser group. Assuming an attrition rate of 20%, we plan a sample size of 36 (18+18).
The estimate of the efficacy of laser hair removal to decrease pilonidal disease recurrence in darker skin adolescents/young adults from this pilot study is needed to design and perform a critical multi-institutional trial. A focused study of laser hair depilation in patients with darker skin types is essential to promote equitable health care across all patients with pilonidal disease by targeted inclusion of underrepresented populations with darker skin types in a therapeutic trial. Community engagement and partnership with Delaware communities that represent these populations will be critical to engage these underrepresented populations in research and to disseminate and implement research findings into these communities.
- Conditions
- Pilonidal Disease
- Being tested
- Laser hair depilation, Standard of Care (SOC)
- Keywords
- laser hair depilation, pilonidal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser hair depilationProcedure or surgery
Also called laser hair removal, laser epilation
Laser hair depilation treatment with Nd:YAG laser every 4-6 weeks until 90% hair reduction is achieved as determined by clinical evaluation. 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.
Standard of Care (SOC)Other
The control group will be provided with the "best recommended standard of care" based on recommendations from published studies and guidelines7,31-34 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. Patients and families in the control group will be taught hair removal techniques and the technique of mechanical depilation will be demonstrated for the patient and caregiver with the nurse or physician shaving the gluteal cleft of the patient during this visit. It will be recommended that they perform either chemical (cream application as directed) or mechanical depilation (shaving) as needed to keep the area hair free. The choice between chemical or mechanical depilation is up to the patient and family.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Other | 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. Receives: Other: Standard of Care (SOC) |
| Laser group | Experimental | Description: Laser hair depiction treatment with Nd:YAG laser every 4-6 weeks until 90% hair reduction is achieved as determined by clinical evaluation. 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. Receives: Procedure: Laser hair depilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Recurrence
Disease recurrence is defined as development of a new pilonidal abscess, folliculitis, or draining sinus after treatment, which would require antibiotic therapy, additional 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).
Measured: 1 year
Secondary outcomes (5)
Disability days
Disability days will be defined as all days in which the patient was not able to participate in all normal activities secondary to pilonidal disease within 1 year.
Measured: 1 year
health-related quality of life (HRQOL) and healthcare satisfaction
The PedsQLTM Quality of Life Inventory: Child and Parent Report questionnaire will be used to assess HRQOL. The PedsQLTM Healthcare Satisfaction Generic Module: Parent Report will be used to assess healthcare satisfaction.
Measured: 1 year
Rates of pilonidal disease-related complications
Complications include physician, Emergency Department (ED), and urgent care visits, hospital admissions, and additional surgical procedures.
Measured: 1 year
Rates of pilonidal disease-related procedures
Procedures will include incision and drainage procedures and surgical excisions, and their respective post-operative complications
Measured: 1 year
Rates of compliance with recommended treatment
Proportion of patients completing the assigned treatments (laser session or hair removal at home)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Oct 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to intervention or control group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Peter Minneci, Nemours Children's Clinic
- Investigators
- Peter C Minneci, Principal investigator, Nemours Children's Health Delaware Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406621
- Sponsor's protocol ID
- ITP20243485
- Other IDs
- U54GM104941
- Status last verified
- Oct 2026
- First submitted
- 6 May 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial Assessing the Effectiveness of Laser Hair Depilation on Pilonidal Disease Recurrence in Patients With Darker Skin Color
- ClinicalTrials.gov ID
- NCT06406621
- Acronym / sponsor ID
- ITP20243485
- Conditions
- Pilonidal Disease
- Keywords
- laser hair depilation, pilonidal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot randomized trial assessing the effectiveness of laser hair depilation on pilonidal disease recurrence in patients with darker skin color
Detailed description
Pilonidal disease is a painful skin infection that occurs in the crease of the buttocks near the tailbone (gluteal cleft) and affects approximately 1% of the population between the ages of 15-30 years. Medical therapy of pilonidal disease is largely dependent upon continued hair removal, meticulous hygiene to the area, and recurrent courses of antibiotics with intermittent incision and drainage procedures. However, recurrent pilonidal disease after initial incision and drainage can be as high as 40% and wound complications after resection have been reported to be as high as 30%. Recurrence often leads to a substantial burden on patients with dependence on caregivers, long term disability, reduced quality of life, and social withdrawal.
Chronic hair removal to the gluteal cleft is a consistently recommended therapy to prevent pilonidal disease recurrence. Research has demonstrated the efficacy of laser hair depilation of the gluteal cleft to reduce pilonidal disease recurrence compared to standard of care in adult and adolescents. A recent randomized controlled trial (RCT) demonstrated laser hair depilation significantly decreased recurrence rates at 1 year from 33% to 10%. However, in exploratory secondary analyses, there was potential heterogeneity of treatment effect based on self-reported race and ethnicity. Although limited by small numbers of patients in many of the racial and ethnic groups, there was a significant reduction in disease recurrence among Non-Hispanic White patients with laser treatment but no change in recurrence among all other groups.
This study will investigate the effects of laser hair depilation on pilonidal disease recurrence among those with darker skin types. We will perform a pilot RCT comparing laser hair depilation and mechanical/chemical depilation (intervention group) to mechanical/chemical depilation alone (control group). The rate of recurrence of pilonidal disease at 1 year will be compared between the two groups. 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. 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 differences in the 1-year morbidity associated with pilonidal disease between the two groups. We hypothesize that laser hair depilation will lead to less morbidity including less disability, higher health related quality of life, higher healthcare satisfaction, and fewer procedures, surgical excisions, and post-operative complications.
This is an exploratory pilot trial aimed at generating an effect size to inform the design of a larger confirmatory study with formal hypothesis testing. The recurrence rate within 1 year is expected to be 30% in the control group, while it is unknown in the laser group, with an expectation of a substantially lower rate in this group. A sample size of 30 patients (15 in each group) can detect an absolute reduction of 29% in the recurrence rate in the laser group compared to the control group, with a power of 80% at a significance level of 0.05. However, we anticipate a minimum reduction of 10% in the recurrence rate in the laser group. The planned sample size of 30 patients will yield a two-sided 95% confidence interval with a precision of 0.31 (half-width) to estimate this difference when the recurrence rate is 30% in the control group and 20% in the laser group. Assuming an attrition rate of 20%, we plan a sample size of 36 (18+18).
The estimate of the efficacy of laser hair removal to decrease pilonidal disease recurrence in darker skin adolescents/young adults from this pilot study is needed to design and perform a critical multi-institutional trial. A focused study of laser hair depilation in patients with darker skin types is essential to promote equitable health care across all patients with pilonidal disease by targeted inclusion of underrepresented populations with darker skin types in a therapeutic trial. Community engagement and partnership with Delaware communities that represent these populations will be critical to engage these underrepresented populations in research and to disseminate and implement research findings into these communities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to intervention or control group
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Other | Other: Standard of Care (SOC)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. |
| Laser group | Experimental | Procedure: Laser hair depilationDescription: Laser hair depiction treatment with Nd:YAG laser every 4-6 weeks until 90% hair reduction is achieved as determined by clinical evaluation. 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. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age: 10-21 years
- Diagnosis of pilonidal disease
- Fitzpatrick skin type IV, V, or VI
Key exclusion criteria (2 listed)
- History of photosensitivity
- Actively inflamed pilonidal sinus (will be offered enrollment upon resolution).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser hair depilationAlso: laser hair removal, laser epilationLaser hair depilation treatment with Nd:YAG laser every 4-6 weeks until 90% hair reduction is achieved as determined by clinical evaluation. 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. | Procedure or surgery | Laser group |
| Standard of Care (SOC)The control group will be provided with the "best recommended standard of care" based on recommendations from published studies and guidelines7,31-34 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. Patients and families in the control group will be taught hair removal techniques and the technique of mechanical depilation will be demonstrated for the patient and caregiver with the nurse or physician shaving the gluteal cleft of the patient during this visit. It will be recommended that they perform either chemical (cream application as directed) or mechanical depilation (shaving) as needed to keep the area hair free. The choice between chemical or mechanical depilation is up to the patient and family. | Other | Standard Care |
Primary outcome
Disease Recurrence
Time frame: 1 year
Disease recurrence is defined as development of a new pilonidal abscess, folliculitis, or draining sinus after treatment, which would require antibiotic therapy, additional 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).
5 secondary outcomes
Disability days
Time frame: 1 year
health-related quality of life (HRQOL) and healthcare satisfaction
Time frame: 1 year
Rates of pilonidal disease-related complications
Time frame: 1 year
Rates of pilonidal disease-related procedures
Time frame: 1 year
Rates of compliance with recommended treatment
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter C Minneci principal investigator
Nemours Children's Health Delaware Valley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser hair depilation in people with Pilonidal Disease, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Minneci, MD (302-333-9549, peter.minneci@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Recurrence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.