Evaluating the Safety and Efficacy of Laight®-Therapy Treatment in Subjects With Hidradenitis Suppurativa

Study 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. HS affects more women than men in a ratio of approximately 3:1, and onset of the disease is typically after puberty. 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. 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. 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. 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 in

Primary Outcome

Classification of HS severity Participant treatment location will be assessed using the Hurley Staging scale Stage I (Mild) Inflammatory nodule or abscess formation, single or multiple, without sinus tracts and scarring Stage II (Moderate) Recurrent abscesses and nodules with sinus tract formation or scarring: single or multiple widely separated lesions Stage III (Severe) Diffuse or near-diffuse involvement with multiple interconnected sinus tracts, scarring, and abscesses across entire area

Interventions

• DEVICE Laight therapy, NICE V3.1 device