Laser Hair Removal for Treatment of Pilonidal Disease

Pilonidal Disease Clinical Trial

Official title:

Laser Hair Removal for Primary Treatment of Pilonidal Disease Requiring Surgical Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949140
• Other study ID #: 2018-1031
• Secondary ID: Protocol Version
• Status: Completed
• Phase: N/A
• Start date: February 18, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: December 2021
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Pilonidal Disease

Intervention

Procedure:
• Laser hair removal
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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Syneron Candela

Country where clinical trial is conducted

United States, 

References & Publications (16)

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;(1):CD006213. doi: 10.1002/14651858.CD006213.pub3. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View 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. Review. — View Citation

Søndenaa K, Andersen E, Nesvik I, Søreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. — View Citation

Søndenaa K, Pollard ML. Histology of chronic pilonidal sinus. APMIS. 1995 Apr;103(4):267-72. — View Citation

Stauffer VK, Luedi MM, Kauf P, Schmid M, Diekmann M, Wieferich K, Schnüriger 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. — View 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. — View Citation

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. Epub 2006 Apr 1. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	up to 2 years
Secondary	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.	Up to 18 months
Secondary	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.	up to 18 months
Secondary	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.	up to 18 months
Secondary	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.	up to 2 years