Pilot Study of Laser Hair Depilation for Pilonidal Disease

Pilonidal Disease Clinical Trial

Official title:

Pilonidal Disease Laser Depilation Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778152
• Other study ID #: 16-00104
• Status: Completed
• Phase: N/A
• Start date: February 19, 2016
• Est. completion date: February 2, 2018

Study information

• Verified date: March 2019
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Pilonidal Disease

Intervention

Device:
• Laser depilation
Laser depilation of natal cleft (pilonidal region)

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Peter Minneci

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of Laser Treatment	Median of pain scores immediately post-laser treatment after each of the 5 treatments. Pain was assessed on a scale of 1 to 10, 10 being the greatest amount of pain.	five months
Secondary	Number of Participants Experiencing Second Degree Burns Post-Treatment	Incidence of skin burn within the first 48 hours after each of the 5 treatments	five months