search
Back to results

Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alexandrite Laser
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring hidradenitis suppurativa, hidradenitis, laser

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Wayne State University Physician Group Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Arm

Control Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HiSCR
Change in Hidradenitis Suppurativa Clinical Response Scale from baseline

Full Information

First Posted
February 9, 2017
Last Updated
May 12, 2023
Sponsor
Wayne State University
search

1. Study Identification

Unique Protocol Identification Number
NCT03054155
Brief Title
Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser
Official Title
Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients with bilateral disease will be chosen to participate in the study. Patients will be advised to discontinue any prior systemic HS treatments two weeks before their first laser session as a wash out period. One side of the patient will be chosen as the treatment side, the other as an intrinsic control. Each participant will have a total of 4 treatments with the laser, one treatment per month over the duration of 4 months. Patients will then participate in a follow-up clinic visit two months after completion of their last treatment. In between laser sessions, participants will be allowed to use benzoyl peroxide 10% wash as a skin cleanser and clindamycin 1% solution or lotion as a topical therapy, both twice daily to the treatment and control areas. At each visit, photographs will be taken of the lesions to monitor progression and to serve as a comparison to the control side. The treatment side will be treated with the laser and adjusted according to skin type as follows: Skin type I-II (Fair Caucasian): Fluence: 30J/cm2 Skin type III (Darker Caucasian, light Asian): Fluence: 25 J/cm2 Skin type IV (Mediterranean, Asian, Latin): Fluence: 18 J/cm2 Skin type V (Light skinned black, Darker mediterranean): Fluence: 16J/cm2 Skin type VI (Dark skinned black): Fluence 14 J/cm2 A spot size of 12 mm and a cryogen spray delay of 50/50 will be used for all treated patients. The treatment area will not exceed 15cm x 15cm. If the patient cannot tolerate treatment with the Alexandrite laser, the patient will be terminated from the study. Following each treatment session, the patient will be given an ice pack to reduce any discomfort the patient may experience as a result of treatment with the laser. Clinical evaluation and photographs will determine improvement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
hidradenitis suppurativa, hidradenitis, laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
For each patient, one side of the body will serve as the treatment side and the other side as the control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
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
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Alexandrite Laser
Intervention Description
Alexandrite 755nm hair removal laser
Primary Outcome Measure Information:
Title
HS-LASI
Description
Change in Hidradenitis Suppurativa Lesion, Area, and Severity Index Score from baseline
Time Frame
Monthly for 4 months, then once 2 months later(6 months total)
Secondary Outcome Measure Information:
Title
HiSCR
Description
Change in Hidradenitis Suppurativa Clinical Response Scale from baseline
Time Frame
Monthly for 4 months, then once 2 months later(6 months total)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-65 Patients with Hidradenitis Suppurativa with bilateral and symmetric disease with one or more anatomic sites of involvement. Exclusion Criteria: 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
Facility Information:
Facility Name
Wayne State University Physician Group Dermatology
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19438670
Citation
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.
Results Reference
background
PubMed Identifier
20227579
Citation
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.
Results Reference
background
PubMed Identifier
26201313
Citation
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.
Results Reference
background

Learn more about this trial

Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser

We'll reach out to this number within 24 hrs