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

NCT05927948 | Completed DMC FDA Device

• 1 other identifier: IRB11922
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Hurley Stage

  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

  22 weeks

Secondary Outcomes (5)

• Hidradenitis Suppurativa Clinical Response Score

  baseline and end of treatment (22 weeks)

• Dermatology Life Quality Index

  baseline and end of treatment (22 weeks)

• Hidradenitis suppurativa physician global assessment

  baseline and end of treatment (22 weeks)

• International HS Severity Scoring

  baseline and end of treatment (22 weeks)

• Pain Visual Analog Scale

  22 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

This is a split body study. The patients will serve as their own control. The side that receives Laight therapy will be randomized. For example, if the patient receives Laight therapy on the right, then the control will be the left.

Device: Laight therapy, NICE V3.1 device

Control

NO INTERVENTION

This is a split body study. The patients will serve as their own control. The control side of the body will be randomized. For example, if the patient receives Laight therapy on the right, then the control will be the left.

Interventions

Laight therapy, NICE V3.1 device DEVICE

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years old.
• Have a diagnosis of Hurley stage I or II HS.
• Patients must have bilateral HS in the axilla, groin, or breast.
• Hurley stage 1 or 2 disease in either the axillae, groin, or inframammary locations.
• At least 2 clinically observable lesions in the axilla, groin or breast.
• Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form.
• Agree to follow and undergo all study-related procedures.

You may not qualify if:

• No diagnosis of HS in the axillae or groin.
• Tattoos located on proposed treatment locations.
• Metal implants of intended treatment areas.
• History of acne conglobata.
• Concomitant use of antibiotics in the tetracycline class or oral or topical retinoids (permitted with 14-day washout period).
• Concomitant use of biologic medications (6-month washout period).
• Concomitant use of other topical treatments of HS in intended treatment locations (14-day washout period), except for topical benzoyl peroxide or topical clindamycin gel or lotion.
• History of melanoma.
• Active skin cancer in the proposed treatment area (non-melanoma in the past 6 month).
• Current Nd:YAG laser hair removal for HS treatment in the study area.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital Systems- New Center One

Detroit, Michigan, 48202, United States

Location

Related Publications (2)

• Tierney E, Mahmoud BH, Hexsel C, Ozog D, Hamzavi I. Randomized control trial for the treatment of hidradenitis suppurativa with a neodymium-doped yttrium aluminium garnet laser. Dermatol Surg. 2009 Aug;35(8):1188-98. doi: 10.1111/j.1524-4725.2009.01214.x. Epub 2009 May 12.

  PMID: 19438670 BACKGROUND

• Wilden S, Friis M, Tuettenberg A, Staubach-Renz P, Wegner J, Grabbe S, von Stebut E. Combined treatment of hidradenitis suppurativa with intense pulsed light (IPL) and radiofrequency (RF). J Dermatolog Treat. 2021 Aug;32(5):530-537. doi: 10.1080/09546634.2019.1677842. Epub 2019 Oct 17.

  PMID: 31609667 BACKGROUND

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Iltefat Hamzavi

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: July 3, 2023
• Study Start: November 4, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)