NCT05927948

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

Completed NA Last updated 9 October 2024

What this trial tests

NA trial testing Laight therapy, NICE V3.1 device in Hidradenitis Suppurativa in 10 participants. Completed in 1 December 2021.

Timeline

4 November 2019

Primary endpoint
1 December 2020

1 December 2021

Quick facts

Lead sponsor	Henry Ford Health System
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	10
Start date	4 November 2019
Primary completion	1 December 2020
Estimated completion	1 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Laight therapy, NICE V3.1 device

Conditions studied

• Hidradenitis Suppurativa — all drugs for Hidradenitis Suppurativa →

Sponsor

Henry Ford Health System — full company profile →

Who can join

Adults 18 to 100, any sex, with Hidradenitis Suppurativa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 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. 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.