Laser Hair Removal for Treatment of Pilonidal Disease
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|ClinicalTrials.gov Identifier: NCT03949140|
Recruitment Status : Active, not recruiting
First Posted : May 14, 2019
Last Update Posted : August 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pilonidal Disease||Procedure: Laser hair removal||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Laser Hair Removal for Primary Treatment of Pilonidal Disease Requiring Surgical Intervention|
|Actual Study Start Date :||February 18, 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2021|
Experimental: Laser hair removal treatment
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
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.
Other Name: Laser depilation
- 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.
- Characterization of the degree of intervention required to obtain positive results. [ Time Frame: up to 2 years ]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.
- Number of missed school or work days [ Time Frame: Up to 18 months ]This study will investigate qualitative outcomes including the number of missed school or work days at each follow up, 6, 9, and 18 months.
- Assessment of Pain via Promis 3A Pain Short Form [ Time Frame: up to 18 months ]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.
- Number of Days Participants Experience Drainage [ Time Frame: up to 18 months ]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.
- Cost-benefit analysis of laser hair-treated patients versus matched historical control. [ Time Frame: up to 2 years ]Evaluate total cost to the health care system relative to period of disease-free remission.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949140
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53705|