Clinical trial NCT02778152: Pilot Study of Laser Hair Depilation for Pilonidal Disease
Official title: Pilonidal Disease Laser Depilation Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Disease
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 13
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Laser hair removal
Primary purpose: TREATMENT

Brief summary: Pilot study to assess tolerability and safety of laser hair depilation in adolescents and young adults with pilonidal disease.

Detailed description: This is a pilot study to measure safety and tolerance of laser hair depilation in adolescents and young adults with pilonidal disease as a potential treatment to intervene on future recurrence.

Up to a total of 10 patients will be enrolled.

Each patient will be involved in the study for one year. Patients will be brought into Surgery clinic for 1 laser treatment every 4-6 weeks to obtain a total of 5 treatments. Follow up will occur monthly from the time of initial treatment through 1 year after the last treatment as we evaluate for tolerance and efficacy.

Inclusion Criteria

* English and non-English speaking patients
* All Fitzpatrick skin types
* Age : 12-20 years
* Diagnosis of pilonidal disease

Exclusion Criteria

* History of photosensitivity
* Actively inflamed pilonidal sinus

Laser depilation treatment: Patients will be brought into Surgery clinic for 1 treatment every 4-6 weeks to obtain a total of 5 treatments. The treatment will consist of an 810 nm or Nd:YAG depending on Fitzpatrick skin type and tolerability. A cooling platform and application of topical lidocaine cream will be used to minimize any discomfort associated with the heat of the laser treatments.

Initial follow up for the laser depilation group will be performed to assess for tolerance of the laser treatment. Patients will report their pain every 6 hours for the first 48 hours after their laser hair depilation treatment. Once tolerance is established, patients will return to surgical clinic every month for their laser or placebo visit. After the 5th clinic visit, they will receive a telephone call monthly to assess for any evidence of resolution or recurrence of disease up to 1 year after the completion of the treatments.

Eligibility criteria: Inclusion Criteria:

* English and non-English speaking patients
* All Fitzpatrick skin types
* Age : 12-20 years
* Diagnosis of pilonidal disease

Exclusion Criteria:

* History of photosensitivity
* Actively inflamed pilonidal sinus

Primary outcomes:
measure: Tolerability of Laser Treatment
timeFrame: five months
Secondary outcomes:
measure: Number of Participants Experiencing Second Degree Burns Post-Treatment
timeFrame: five months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Research Institute at Nationwide Children's Hospital
name: Peter C Minneci, MD
role: PRINCIPAL_INVESTIGATOR
References: