Evaluating the Safety and Efficacy of Laight®-Therapy Treatment in Subjects With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional

Summary: 
      Hidradenitis suppurativa (HS) is a debilitating and chronic condition characterized by
      recurrent episodes of inflammation associated with the formation of abscesses, inflammatory
      nodules, pain, and drainage ultimately culminating in the formation of scarring in moderate
      to severe disease.1 HS affects more women than men in a ratio of approximately 3:1, and onset
      of the disease is typically after puberty.2 The axillae, breasts, groin, buttocks, and lower
      abdomen are common intertriginous regions which are affected by HS, and significant impacts
      on quality of life are reported in the literature.1 The Hurley Staging system is commonly
      utilized to classify the severity of a patient's hidradenitis suppurativa. Stage 1 disease
      consists of one or more abscesses with no sinus tract formation or scarring. Stage 2 disease
      involves one or more widely separated recurrent abscesses, with formation of a sinus tract
      and/or scarring. Stage 3 involves multiple interconnected sinus tracts and/or abscesses
      throughout an anatomical area.

      Histologic studies of HS suggest that follicular hyperkeratosis and obstruction is the
      primary event in the pathogenesis. Subsequently, there is rupture of the follicular
      infundibulum and a resulting inflammatory cascade. Despite recurrent episodes of purulent
      drainage, bacteria do not appear to play a primary role in the pathogenesis.3 The traditional
      repertoire of treatment options for HS can be divided into medical and surgical options,
      however there is currently no cure for HS and treatments focus on symptomatic control.
      Medical treatments including topical and systemic antibiotics, hormonal agents, and biologic
      medications can successfully control symptoms however discontinuation of many of these is
      associated with relapses in disease symptoms.4,5 Conversely, surgical interventions such as
      traditional surgical excision performed in an operating room, or carbon dioxide laser
      excision performed under local anesthetic in an outpatient setting can induce long term
      symptom control however may not be appropriate for all patients considering the risk of
      general anesthesia, high cost of inpatient hospitalizations, and cumbersome healing process
      for procedures which heal by secondary intention.6 Despite numerous treatment options for HS,
      efficacious and non-invasive treatment options which result in long term remission of disease
      are needed to meet the needs of HS patients.
    

Detailed description: 
      Subjects receive treatment every 2 weeks for a total of 22 weeks, 10 treatments. Subject
      treatment side will be randomized via computer generated assignments.

      Ultrasound imaging will be utilized to assess abscesses, nodules, and sinus tracts at
      investigator discretion. Patient-reported outcome measures include DLQI and Pain VAS.
      Physician-reported outcome measures include: HS-PGA, IHS4, Hurley Staging, and HiSCR.
    

Intervention name(s): Laight therapy, NICE V3.1 device
Intervention type(s): Device
Intervention description(s): Laight therapy is a non-invasive method of treatment for HS and acne developed in Germany which utilizes a combination of radiofrequency and intense pulsed light exposure. Three passes of the device, all coupled with radiofrequency, are used in the proposed treatment area. The first pass encompasses wavelengths between 420 nm and 1200 nm, the second between 510 nm and 1200 nm, and the third pass between 690 nm and 1200 nm.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: The patient has one side exposed to treatment and the other side receives no treatment as the comparison. Hence, patient serves as their own control.
Masking: None (Open Label)
Primary purpose: Other