Pilonidal DiseaseNCT03949140
Laser Hair Removal for Treatment of Pilonidal Disease
A study testing Laser hair removal in people with Pilonidal Disease, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This project is a pilot study to determine if symptomatic pilonidal disease can be primarily managed with laser hair removal vs surgery. Read more about this study
- Who is it for?
- Ages 13 to 35 years
- Conditions the study is for
- Pilonidal Disease
- What is being tested?
- Laser hair removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2019to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with symptomatic pilonidal disease, who meet criteria for surgical intervention:
- Experience two or more episodes of infection or abscess in the past 12 months
- Have pain or drainage for a total of more than 1 month in the past 12 months
- Missed a total of more than 1 week of school or work in the past 12 months
- English-speaking
Who cannot join
- Patients who have co-morbidities that prevent them from becoming a surgical candidate
- Previous history of laser hair removal in the gluteal cleft (prior to initial enrollment)
- Previous excision of pilonidal sinus (prior to initial enrollment)
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser Hair Removal for Primary Treatment of Pilonidal Disease Requiring Surgical Intervention
This project is a pilot study to determine if symptomatic pilonidal disease can be primarily managed with laser hair removal vs surgery.
Read the detailed description
This project will consist of surgical evaluation in pediatric surgery or colorectal surgery clinics, referral to dermatology clinic for informed consent, and if enrolled, participation in up to 8 laser hair removal sessions with regular follow-up for a period of 2 years after completion of therapy.
- Conditions
- Pilonidal Disease
- Being tested
- Laser hair removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser hair removalProcedure or surgery
Also called Laser depilation
Those who consent to participate in the study will be treated with up to 8 sessions of laser hair removal utilizing a long-pulsed laser to the natal cleft at treatment intervals of 4-6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Laser hair removal treatment | Experimental | Patients who choose to enroll will plan to undergo a total of up to 8 laser hair removal sessions every 4-6 weeks. If patients develop abscess or infection during this time, they will undergo I\&D and/or antibiotics, consistent with standard therapy for infection or abscess. If patients have 2 or more infections in 1 year, pain or drainage for more than 1 month, or miss more than 1 week of school or work due to ineffective treatment of pilonidal disease, these patients will undergo surgical excision and subsequent follow-up at surgeon's discretion. Patients will follow up at 2-4-week intervals for 3 months, then at 6, 9, and 18 months after conclusion of the laser therapy sessions. At all follow-up sessions, patients will be given the DQLI, CDQLI, and Promis 3A Pain survey. Unscheduled visits such as unplanned clinic visits, emergency department encounters, and hospitalizations, will be included in data collected for analysis of primary and secondary outcomes. Receives: Procedure: Laser hair removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of disease-free remission
Disease free rate among those subjects who only required laser therapy. Disease-free remission will be assessed at 12 and 24 months.
Measured: up to 2 years
Disease recurrence rate among subjects who subsequently require surgical intervention.
Rate of recurrence of pilonidal disease among subjects who participated in the study but also required surgical intervention.
Measured: up to 2 years
Secondary outcomes (5)
Characterization of the degree of intervention required to obtain positive results.
Incision and drainage vs. need for larger excision, requirement for oral antibiotics, and the number of emergency room visits, or hospital admissions related to pilonidal disease.
Measured: up to 2 years
Number of missed school or work days
This study will investigate qualitative outcomes including the number of missed school or work days at each follow up, 6, 9, and 18 months.
Measured: Up to 18 months
Assessment of Pain via Promis 3A Pain Short Form
This study will investigate qualitative outcomes including pain. Pain will be assessed via the Promis 3A Pain Short Form at 6, 9, and 18 months. This is a one question survey that has participants rate the intensity of their pain over the last 7 days, on average. The scale is from 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Measured: up to 18 months
Number of Days Participants Experience Drainage
This study will investigate qualitative outcomes including assessment of drainage. This will be reported as the number of days participants experienced drainage since last follow up, assessed at 6, 9, and 18 month follow up.
Measured: up to 18 months
Cost-benefit analysis of laser hair-treated patients versus matched historical control.
Evaluate total cost to the health care system relative to period of disease-free remission.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start18 Feb 2019
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Pilonidal DiseaseStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Syneron Candela
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949140
- Sponsor's protocol ID
- 2018-1031
- Other IDs
- Protocol Version 6, A539790, SMPH/SURGERY/PEDIATRIC SURGERY
- Status last verified
- Dec 2021
- First submitted
- 16 Nov 2018
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
von Laffert M, Stadie V, Ulrich J, Marsch WC, Wohlrab J. Morphology of pilonidal sinus disease: some evidence of its being a unilocalized type of hidradenitis suppurativa. Dermatology. 2011;223(4):349-55. doi: 10.1159/000335373. Epub 2012 Jan 21.
PubMed 22269798Sondenaa K, Pollard ML. Histology of chronic pilonidal sinus. APMIS. 1995 Apr;103(4):267-72. doi: 10.1111/j.1699-0463.1995.tb01105.x.
PubMed 7542011Sondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585.
PubMed 7745322Al-Khamis A, McCallum I, King PM, Bruce J. Healing by primary versus secondary intention after surgical treatment for pilonidal sinus. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006213. doi: 10.1002/14651858.CD006213.pub3.
PubMed 20091589Steele SR, Perry WB, Mills S, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of pilonidal disease. Dis Colon Rectum. 2013 Sep;56(9):1021-7. doi: 10.1097/DCR.0b013e31829d2616. No abstract available.
PubMed 23929010Stauffer VK, Luedi MM, Kauf P, Schmid M, Diekmann M, Wieferich K, Schnuriger B, Doll D. Common surgical procedures in pilonidal sinus disease: A meta-analysis, merged data analysis, and comprehensive study on recurrence. Sci Rep. 2018 Feb 15;8(1):3058. doi: 10.1038/s41598-018-20143-4.
PubMed 29449548Doll D, Krueger CM, Schrank S, Dettmann H, Petersen S, Duesel W. Timeline of recurrence after primary and secondary pilonidal sinus surgery. Dis Colon Rectum. 2007 Nov;50(11):1928-34. doi: 10.1007/s10350-007-9031-4.
PubMed 17874268Khan MA, Javed AA, Govindan KS, Rafiq S, Thomas K, Baker L, Kenealy J. Control of hair growth using long-pulsed alexandrite laser is an efficient and cost effective therapy for patients suffering from recurrent pilonidal disease. Lasers Med Sci. 2016 Jul;31(5):857-62. doi: 10.1007/s10103-016-1920-0. Epub 2016 Mar 22.
PubMed 27003897Dragoni F, Moretti S, Cannarozzo G, Campolmi P. Treatment of recurrent pilonidal cysts with nd-YAG laser: report of our experience. J Dermatolog Treat. 2018 Feb;29(1):65-67. doi: 10.1080/09546634.2017.1329513. Epub 2017 May 30.
PubMed 28521574Oram Y, Kahraman F, Karincaoglu Y, Koyuncu E. Evaluation of 60 patients with pilonidal sinus treated with laser epilation after surgery. Dermatol Surg. 2010;36(1):88-91. doi: 10.1111/j.1524-4725.2009.01387.x. Epub 2009 Dec 4.
PubMed 20002644Pronk AA, Eppink L, Smakman N, Furnee EJB. The effect of hair removal after surgery for sacrococcygeal pilonidal sinus disease: a systematic review of the literature. Tech Coloproctol. 2018 Jan;22(1):7-14. doi: 10.1007/s10151-017-1722-9. Epub 2017 Nov 28.
PubMed 29185064Toosi P, Sadighha A, Sharifian A, Razavi GM. A comparison study of the efficacy and side effects of different light sources in hair removal. Lasers Med Sci. 2006 Apr;21(1):1-4. doi: 10.1007/s10103-006-0373-2. Epub 2006 Apr 1.
PubMed 16583183Nanni CA, Alster TS. Laser-assisted hair removal: side effects of Q-switched Nd:YAG, long-pulsed ruby, and alexandrite lasers. J Am Acad Dermatol. 1999 Aug;41(2 Pt 1):165-71. doi: 10.1016/s0190-9622(99)70043-5.
PubMed 10426883Mutus HM, Aksu B, Uzun E, Gulcin N, Gercel G, Ozatman E, Durakbasa CU, Okur H. Long-term analysis of surgical treatment outcomes in chronic pilonidal sinus disease. J Pediatr Surg. 2018 Feb;53(2):293-294. doi: 10.1016/j.jpedsurg.2017.11.031. Epub 2017 Nov 14.
PubMed 29217319Pascoe VL, Kimball AB. Seasonal variation of acne and psoriasis: A 3-year study using the Physician Global Assessment severity scale. J Am Acad Dermatol. 2015 Sep;73(3):523-5. doi: 10.1016/j.jaad.2015.06.001. No abstract available.
PubMed 26282801
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Hair Removal for Primary Treatment of Pilonidal Disease Requiring Surgical Intervention
- ClinicalTrials.gov ID
- NCT03949140
- Acronym / sponsor ID
- 2018-1031
- Conditions
- Pilonidal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Syneron Candela
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is a pilot study to determine if symptomatic pilonidal disease can be primarily managed with laser hair removal vs surgery.
Detailed description
This project will consist of surgical evaluation in pediatric surgery or colorectal surgery clinics, referral to dermatology clinic for informed consent, and if enrolled, participation in up to 8 laser hair removal sessions with regular follow-up for a period of 2 years after completion of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser hair removal treatment | Experimental | Procedure: Laser hair removalPatients who choose to enroll will plan to undergo a total of up to 8 laser hair removal sessions every 4-6 weeks. If patients develop abscess or infection during this time, they will undergo I\&D and/or antibiotics, consistent with standard therapy for infection or abscess. If patients have 2 or more infections in 1 year, pain or drainage for more than 1 month, or miss more than 1 week of school or work due to ineffective treatment of pilonidal disease, these patients will undergo surgical excision and subsequent follow-up at surgeon's discretion. Patients will follow up at 2-4-week intervals for 3 months, then at 6, 9, and 18 months after conclusion of the laser therapy sessions. At all follow-up sessions, patients will be given the DQLI, CDQLI, and Promis 3A Pain survey. Unscheduled visits such as unplanned clinic visits, emergency department encounters, and hospitalizations, will be included in data collected for analysis of primary and secondary outcomes. |
Who may qualify
- Ages
- 13 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Experience two or more episodes of infection or abscess in the past 12 months
- Have pain or drainage for a total of more than 1 month in the past 12 months
- Missed a total of more than 1 week of school or work in the past 12 months
- English-speaking
Key exclusion criteria (4 listed)
- Patients who have co-morbidities that prevent them from becoming a surgical candidate
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 hair removalAlso: Laser depilationThose who consent to participate in the study will be treated with up to 8 sessions of laser hair removal utilizing a long-pulsed laser to the natal cleft at treatment intervals of 4-6 weeks. | Procedure or surgery | Laser hair removal treatment |
Primary outcome
Incidence of disease-free remission
Time frame: up to 2 years
Disease free rate among those subjects who only required laser therapy. Disease-free remission will be assessed at 12 and 24 months.
Disease recurrence rate among subjects who subsequently require surgical intervention.
Time frame: up to 2 years
Rate of recurrence of pilonidal disease among subjects who participated in the study but also required surgical intervention.
5 secondary outcomes
Characterization of the degree of intervention required to obtain positive results.
Time frame: up to 2 years
Number of missed school or work days
Time frame: Up to 18 months
Assessment of Pain via Promis 3A Pain Short Form
Time frame: up to 18 months
Number of Days Participants Experience Drainage
Time frame: up to 18 months
Cost-benefit analysis of laser hair-treated patients versus matched historical control.
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Background: PubMed 22269798von Laffert M, Stadie V, Ulrich J, Marsch WC, Wohlrab J. Morphology of pilonidal sinus disease: some evidence of its being a unilocalized type of hidradenitis suppurativa. Dermatology. 2011;223(4):349-55. doi: 10.1159/000335373. Epub 2012 Jan 21.
- Background: PubMed 7542011Sondenaa K, Pollard ML. Histology of chronic pilonidal sinus. APMIS. 1995 Apr;103(4):267-72. doi: 10.1111/j.1699-0463.1995.tb01105.x.
- Background: PubMed 7745322Sondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585.
- Background: PubMed 20091589Al-Khamis A, McCallum I, King PM, Bruce J. Healing by primary versus secondary intention after surgical treatment for pilonidal sinus. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006213. doi: 10.1002/14651858.CD006213.pub3.
- Background: PubMed 23929010Steele SR, Perry WB, Mills S, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of pilonidal disease. Dis Colon Rectum. 2013 Sep;56(9):1021-7. doi: 10.1097/DCR.0b013e31829d2616. No abstract available.
- Background: PubMed 29449548Stauffer VK, Luedi MM, Kauf P, Schmid M, Diekmann M, Wieferich K, Schnuriger B, Doll D. Common surgical procedures in pilonidal sinus disease: A meta-analysis, merged data analysis, and comprehensive study on recurrence. Sci Rep. 2018 Feb 15;8(1):3058. doi: 10.1038/s41598-018-20143-4.
- Background: PubMed 17874268Doll D, Krueger CM, Schrank S, Dettmann H, Petersen S, Duesel W. Timeline of recurrence after primary and secondary pilonidal sinus surgery. Dis Colon Rectum. 2007 Nov;50(11):1928-34. doi: 10.1007/s10350-007-9031-4.
- Background: PubMed 27003897Khan MA, Javed AA, Govindan KS, Rafiq S, Thomas K, Baker L, Kenealy J. Control of hair growth using long-pulsed alexandrite laser is an efficient and cost effective therapy for patients suffering from recurrent pilonidal disease. Lasers Med Sci. 2016 Jul;31(5):857-62. doi: 10.1007/s10103-016-1920-0. Epub 2016 Mar 22.
- Background: PubMed 28521574Dragoni F, Moretti S, Cannarozzo G, Campolmi P. Treatment of recurrent pilonidal cysts with nd-YAG laser: report of our experience. J Dermatolog Treat. 2018 Feb;29(1):65-67. doi: 10.1080/09546634.2017.1329513. Epub 2017 May 30.
- Background: PubMed 20002644Oram Y, Kahraman F, Karincaoglu Y, Koyuncu E. Evaluation of 60 patients with pilonidal sinus treated with laser epilation after surgery. Dermatol Surg. 2010;36(1):88-91. doi: 10.1111/j.1524-4725.2009.01387.x. Epub 2009 Dec 4.
- Background: PubMed 29185064Pronk AA, Eppink L, Smakman N, Furnee EJB. The effect of hair removal after surgery for sacrococcygeal pilonidal sinus disease: a systematic review of the literature. Tech Coloproctol. 2018 Jan;22(1):7-14. doi: 10.1007/s10151-017-1722-9. Epub 2017 Nov 28.
- Background: PubMed 16583183Toosi P, Sadighha A, Sharifian A, Razavi GM. A comparison study of the efficacy and side effects of different light sources in hair removal. Lasers Med Sci. 2006 Apr;21(1):1-4. doi: 10.1007/s10103-006-0373-2. Epub 2006 Apr 1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 hair removal in people with Pilonidal Disease, run by University of Wisconsin, Madison 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 5 inclusion and 4 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 17 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of disease-free remission (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949140, which also lists 16 linked publications.
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 17 Dec 2021.