Laser Hair Removal for Treatment of Pilonidal Disease

NCT03949140 | Completed

• 4 other identifiers: 2018-1031Protocol Version 6A539790SMPH/SURGERY/PEDIATRIC SURGERY
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This project is a pilot study to determine if symptomatic pilonidal disease can be primarily managed with laser hair removal vs surgery.

Conditions

Pilonidal Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  up to 2 years

Secondary Outcomes (5)

• Characterization of the degree of intervention required to obtain positive results.

  up to 2 years

• Number of missed school or work days

  Up to 18 months

• Assessment of Pain via Promis 3A Pain Short Form

  up to 18 months

• Number of Days Participants Experience Drainage

  up to 18 months

• Cost-benefit analysis of laser hair-treated patients versus matched historical control.

  up to 2 years

Study Arms (1)

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.

Procedure: Laser hair removal

Interventions

Laser hair removal PROCEDURE

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.

Also known as: Laser depilation

Laser hair removal treatment

Eligibility Criteria

• Age: 13 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Syneron Candela: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (16)

• 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.

  PMID: 22269798 BACKGROUND

• 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.

  PMID: 7542011 BACKGROUND

• 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.

  PMID: 7745322 BACKGROUND

• 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.

  PMID: 20091589 BACKGROUND

• 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.

  PMID: 23929010 BACKGROUND

• 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.

  PMID: 29449548 BACKGROUND

• 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.

  PMID: 17874268 BACKGROUND

• 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.

  PMID: 27003897 BACKGROUND

• 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.

  PMID: 28521574 BACKGROUND

• Oram 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.

  PMID: 20002644 BACKGROUND

• 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.

  PMID: 29185064 BACKGROUND

• Toosi 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.

  PMID: 16583183 BACKGROUND

• 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.

  PMID: 10426883 BACKGROUND

• 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.

  PMID: 29217319 BACKGROUND

• Pascoe 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.

  PMID: 26282801 BACKGROUND

• 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.

  PMID: 25040429 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: May 14, 2019
• Study Start: February 18, 2019
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)