Pilonidal Disease
Conditions
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.
Interventions
DEVICELaser depilation
Laser depilation of natal cleft (pilonidal region)
Sponsors
Peter Minneci
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Laser hair removal
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of Laser Treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Second Degree Burns Post-Treatment | five months | Incidence of skin burn within the first 48 hours after each of the 5 treatments |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laser Depilation 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.
Laser depilation: Laser depilation of natal cleft (pilonidal region) | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Laser Depilation |
|---|---|
| Age, Continuous | 16.6 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
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.
Time frame: five months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Laser Group | Tolerability of Laser Treatment | 2 score on a scale |
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
Time frame: five months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Laser Group | Number of Participants Experiencing Second Degree Burns Post-Treatment | 0 Participants |