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Completed

NCT Number: NCT02778152

Pilot Study of Laser Hair Depilation for Pilonidal Disease

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

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Key information

Conditions

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser depilation

Device

Laser depilation of natal cleft (pilonidal region)

Primary outcomes

  1. Tolerability of Laser Treatment

    Time frame: five months

    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.

Secondary outcomes

  1. Number of Participants Experiencing Second Degree Burns Post-Treatment

    Time frame: five months

    Incidence of skin burn within the first 48 hours after each of the 5 treatments

Sponsors and collaborators

Lead sponsor

Peter Minneci

Other

Registry information

Official study title

Pilonidal Disease Laser Depilation Pilot Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 19, 2016
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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