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Pilot Study of Laser Hair Depilation for Pilonidal Disease

P

Peter Minneci

Status

Completed

Conditions

Pilonidal Disease

Treatments

Device: Laser depilation

Study type

Interventional

Funder types

Other

Identifiers

NCT02778152
16-00104

Details and patient eligibility

About

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

Full 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.

Enrollment

13 patients

Sex

All

Ages

12 to 20 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

Laser depilation
Experimental group
Description:
Laser depilation to the natal cleft (pilonidal region) monthly for 5 treatments with either an 810nm of Nd:YAG laser dependent on Fitzpatrick skin type and tolerability.
Treatment:
Device: Laser depilation

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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