Pilonidal DiseaseNCT02778152
Pilot Study of Laser Hair Depilation for Pilonidal Disease
A study testing Laser depilation in people with Pilonidal Disease, run by Peter Minneci at 1 site in United States.
Trial summary
Pilot study to assess tolerability and safety of laser hair depilation in adolescents and young adults with pilonidal disease. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Pilonidal Disease
- What is being tested?
- Laser depilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2016to 2 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- English and non-English speaking patients
- All Fitzpatrick skin types
- Age : 12-20 years
- Diagnosis of pilonidal disease
Who cannot join
- History of photosensitivity
- Actively inflamed pilonidal sinus
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Pilonidal Disease Laser Depilation Pilot Study
Pilot study to assess tolerability and safety of laser hair depilation in adolescents and young adults with pilonidal disease.
Read the 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.
- Conditions
- Pilonidal Disease
- Being tested
- Laser depilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser depilationDevice
Laser depilation of natal cleft (pilonidal region)
| Study group | Role | What they receive |
|---|---|---|
| Laser depilation | Experimental | 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. Receives: Device: Laser depilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: five months
Secondary outcomes (1)
Number of Participants Experiencing Second Degree Burns Post-Treatment
Incidence of skin burn within the first 48 hours after each of the 5 treatments
Measured: five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start19 Feb 2016
- Primary completion2 Feb 2018
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pilonidal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Laser hair removal
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Minneci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Minneci, Nationwide Children's Hospital
- Investigators
- Peter C Minneci, MD, Principal investigator, Research Institute at Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778152
- Sponsor's protocol ID
- 16-00104
- Status last verified
- Mar 2019
- First submitted
- 17 May 2016
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilonidal Disease Laser Depilation Pilot Study
- ClinicalTrials.gov ID
- NCT02778152
- Acronym / sponsor ID
- 16-00104
- Conditions
- Pilonidal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Peter MinneciUniversity, hospital or other
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Posted 26 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Laser hair removal
| Arm | Type | Receives |
|---|---|---|
| Laser depilation | Experimental | Device: Laser depilationLaser 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. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- English and non-English speaking patients
- All Fitzpatrick skin types
- Age : 12-20 years
- Diagnosis of pilonidal disease
Key exclusion criteria (2 listed)
- History of photosensitivity
- Actively inflamed pilonidal sinus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser depilationLaser depilation of natal cleft (pilonidal region) | Device | Laser depilation |
Primary outcome
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.
1 secondary outcome
Number of Participants Experiencing Second Degree Burns Post-Treatment
Time frame: five months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pilonidal Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter C Minneci, MD principal investigator
Research Institute at Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser depilation in people with Pilonidal Disease, run by Peter Minneci at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of Laser Treatment (time frame: five months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.