Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser

NCT03054155 | Completed FDA Device

• 1 other identifier: 120116M1F
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with bilateral hidradenitis in the axilla, groin and/or inframammary will be treated on one side with the Alexandrite hair removal laser. The other side will serve as the control.

Conditions

Hidradenitis Suppurativa

Keywords

hidradenitis suppurativa; hidradenitis; laser

Outcome Measures

Primary Outcomes (1)

• HS-LASI

  Change in Hidradenitis Suppurativa Lesion, Area, and Severity Index Score from baseline

  Monthly for 4 months, then once 2 months later(6 months total)

Secondary Outcomes (1)

• HiSCR

  Monthly for 4 months, then once 2 months later(6 months total)

Study Arms (2)

Treatment Arm

EXPERIMENTAL

For each patient, one side of the body will be treated with the Alexandrite laser (the treatment arm) and the other will not be treated to serve as control (the control arm). For example, if a patient has the disease in both axillae, one will treatment and the other control

Device: Alexandrite Laser

Control Arm

NO INTERVENTION

For each patient, one side of the body will be treated with the Alexandrite laser (the treatment arm) and the other will not be treated to serve as control (the control arm). For example, if a patient has the disease in both axillae, one will treatment and the other control

Interventions

Alexandrite Laser DEVICE

Alexandrite 755nm hair removal laser

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Patients with Hidradenitis Suppurativa with bilateral and symmetric disease with one or more anatomic sites of involvement.

You may not qualify if:

• Pregnant patients or patients planning to get pregnant during the time of the study
• Patients on systemic treatment for Hidradenitis Suppurativa
• Patients with photosensitivity disorders
• Patients unable to tolerate the laser treatments
• Intake of a photosensitive medication

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University Physician Group Dermatology

Dearborn, Michigan, 48124, United States

Location

Related Publications (3)

• 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

• Mahmoud BH, Tierney E, Hexsel CL, Pui J, Ozog DM, Hamzavi IH. Prospective controlled clinical and histopathologic study of hidradenitis suppurativa treated with the long-pulsed neodymium:yttrium-aluminium-garnet laser. J Am Acad Dermatol. 2010 Apr;62(4):637-45. doi: 10.1016/j.jaad.2009.07.048.

  PMID: 20227579 BACKGROUND

• Kimball AB, Sobell JM, Zouboulis CC, Gu Y, Williams DA, Sundaram M, Teixeira HD, Jemec GB. HiSCR (Hidradenitis Suppurativa Clinical Response): a novel clinical endpoint to evaluate therapeutic outcomes in patients with hidradenitis suppurativa from the placebo-controlled portion of a phase 2 adalimumab study. J Eur Acad Dermatol Venereol. 2016 Jun;30(6):989-94. doi: 10.1111/jdv.13216. Epub 2015 Jul 22.

  PMID: 26201313 BACKGROUND

MeSH Terms

Conditions

Hidradenitis Suppurativa; Hidradenitis

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: For each patient, one side of the body will serve as the treatment side and the other side as the control

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 15, 2017
• Study Start: May 11, 2017
• Primary Completion: September 1, 2022
• Study Completion: October 31, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)