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Trial record 24 of 90 for:    hidradenitis suppurativa

Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser

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ClinicalTrials.gov Identifier: NCT03054155
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Steven D Daveluy, Wayne State University

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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Device: Alexandrite Laser Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Arm
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
Alexandrite 755nm hair removal laser

No Intervention: Control Arm
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



Primary Outcome Measures :
  1. HS-LASI [ Time Frame: Monthly for 4 months, then once 2 months later(6 months total) ]
    Change in Hidradenitis Suppurativa Lesion, Area, and Severity Index Score from baseline


Secondary Outcome Measures :
  1. HiSCR [ Time Frame: Monthly for 4 months, then once 2 months later(6 months total) ]
    Change in Hidradenitis Suppurativa Clinical Response Scale from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054155


Contacts
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Contact: Steven D Daveluy, MD 3134297854 sdaveluy@med.wayne.edu
Contact: Emma Reaves 3134297845 az3432@wayne.edu

Locations
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United States, Michigan
Wayne State University Physician Group Dermatology Recruiting
Dearborn, Michigan, United States, 48124
Contact: Steven D Daveluy, MD    313-429-7854    sdaveluy@med.wayne.edu   
Contact: Emma Reaves    3134297845    az3432@wayne.edu   
Principal Investigator: Steven D Daveluy, MD         
Sub-Investigator: Rachel Ward, MD         
Sub-Investigator: Kristin Totoraitis, BS         
Sponsors and Collaborators
Wayne State University

Publications:
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Responsible Party: Steven D Daveluy, Medical Doctor, Wayne State University
ClinicalTrials.gov Identifier: NCT03054155     History of Changes
Other Study ID Numbers: 120116M1F
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Steven D Daveluy, Wayne State University:
hidradenitis suppurativa
hidradenitis
laser
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration