Clinical trial NCT03949140: Laser Hair Removal for Treatment of Pilonidal Disease
Official title: Laser Hair Removal for Primary Treatment of Pilonidal Disease Requiring Surgical Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Disease
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Syneron Candela
First posted: 2019-05-14
Enrollment: 22
Sex: ALL
Minimum age (years): 13
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of disease-free remission
timeFrame: up to 2 years
measure: Disease recurrence rate among subjects who subsequently require surgical intervention.
timeFrame: up to 2 years
Secondary outcomes:
measure: Characterization of the degree of intervention required to obtain positive results.
timeFrame: up to 2 years
measure: Number of missed school or work days
timeFrame: Up to 18 months
measure: Assessment of Pain via Promis 3A Pain Short Form
timeFrame: up to 18 months
measure: Number of Days Participants Experience Drainage
timeFrame: up to 18 months
measure: Cost-benefit analysis of laser hair-treated patients versus matched historical control.
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References:
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citation: Sondenaa K, Pollard ML. Histology of chronic pilonidal sinus. APMIS. 1995 Apr;103(4):267-72. doi: 10.1111/j.1699-0463.1995.tb01105.x.
citation: Sondenaa 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.
citation: Al-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.
citation: Steele 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.
citation: Stauffer 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.
citation: Doll 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.
citation: Khan 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.
citation: Dragoni 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.
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citation: Pronk 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.
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citation: Nanni 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.
citation: Mutus 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.
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citation: Kimball AB, Jemec GB, Yang M, Kageleiry A, Signorovitch JE, Okun MM, Gu Y, Wang K, Mulani P, Sundaram M. Assessing the validity, responsiveness and meaningfulness of the Hidradenitis Suppurativa Clinical Response (HiSCR) as the clinical endpoint for hidradenitis suppurativa treatment. Br J Dermatol. 2014 Dec;171(6):1434-42. doi: 10.1111/bjd.13270. Epub 2014 Nov 11.