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Control of Hidradenitis Suppurativa of the Underarms After Combination Deroofing and Laser

Primary Purpose

Hidradenitis Suppurativa

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deroofing and laser
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older
  • Diagnosis of hidradenitis suppurativa Hurley stage II with bilateral axillary involvement
  • Must be under the care of a board certified dermatologist and planning to undergo a deroofing procedure of one axilla for the treatment of their HS

  • Disease must be active in the bilateral axillae

    • Activity to be defined as having had at least one flare in the last six months
    • Flare to be defined as patient reported worsening of disease beyond baseline or clinical evidence of active inflammation (i.e. erythema, edema, drainage, tenderness)

Exclusion Criteria:

  • Pregnancy
  • Clinical evidence of active superinfection
  • Previous deroofing surgery in any axilla
  • Previous laser therapy in any axilla

  • Patients on the following medical therapies:

    • Any systemic immunomodulating agent that has been started within 3 months of initial deroofing and laser treatment

      • Patients on immunomodulators >3 months with no change in therapy are eligible for participation

    • Use of topical antibiotics, antiseptics, oral antibiotics, oral steroids, intralesional steroids

      • Patients must have stopped all of these agents at least 2 weeks prior to surgical deroofing

    • Use of intramuscular steroids

      • It must be at least 4 weeks since administration of intramuscular steroids before deroofing for a patient to be eligible for participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    One axilla will be treated with deroofing surgery and laser

    Arm Description

    One axilla will be randomly selected for treatment with deroofing surgery and laser while the other axilla will serve as a control with no treatment for each participant

    Outcomes

    Primary Outcome Measures

    Disease Activity Changes as Assessed by the Hidradenitis Suppurativa Clinical Response
    The Hidradenitis Suppurativa Clinical Response (HiSCR) is a validated score defined as a 50% or greater reduction in abscesses and inflammatory nodule counts with no increase in abscesses and draining sinus tracts at the end of the study period, as compared to baseline. A participant will be considered either positive, or achieving HiSCR, which indicates that the study intervention significantly improved the participant's disease, or the patient will be negative, or did not achieve HiSCR, indicating that the intervention did not significantly impact the participant's disease. Study researchers will calculate this score based on clinical assessment and lesion counts assessed at the first study visit and the last two study visits. The percent of participants who achieve HiSCR at the last two study visits will be reported.
    Disease Activity Changes as Assessed by the International Hidradenitis Suppurativa Severity Score System
    International Hidradenitis Suppurativa Severity Score System (IHS4) changes over the study period will be reported. At each study visit the number of nodules, abscesses, and draining tunnels will be counted in each axilla. The IHS4 score is the number of nodules + abscess count (multiplied by 2) + number of draining tunnels (multiplied by 4). The score can range from 0 lesions and the maximum value is dependent on how many lesions the participant has. The score is used to assess disease severity and can be used to assess how disease severity changes after an intervention. A higher score indicates more active or severe disease, while a lower score indicates less active or less severe disease. Scores throughout the study visits will be reported as well as how these scores change.
    Disease Recurrence after the Intervention as Assessed by Clinical Exam
    During study visits, a study team member will count the number of nodules, abscesses, and tunnels in each axilla. A higher count indicates more active or severe disease, whereas a lower count indicates less active or less severe disease. Scores can range from 0 lesions to as many as the participant has. Differences between the counts throughout the study visits will be reported.

    Secondary Outcome Measures

    Quality of Life Changes as Assessed by the Dermatology Quality of Life Index
    The Dermatology Life Quality Index (DLQI) tool is a validated questionnaire with 10 questions which asks questions related to activities of daily living and how challenging these are in relation a person's skin disease. Answer choices are either yes or no answers or ratings from "not relevant" or "not at all" to "very much" for each question, regarding how their activities of daily living are affected. Scores range from a minimum of 0 to a maximum of 30 with a higher score indicating a worse quality of life. DLQI surveys will be obtained at the first study visit and the final study visit. Score differences between these two visits will be reported.
    Pain as assessed by the Visual Analog Scale
    The Visual Analog Scale is a 10-point validated pain scale which allows a patient to choose a score between 0 to 10 with depictions of faces showing emotions, with 0 being no pain and 10 being the worst possible pain. This questionnaire will be administered at various points throughout the study and changes over time will be reported.

    Full Information

    First Posted
    July 6, 2022
    Last Updated
    July 29, 2022
    Sponsor
    University of Texas at Austin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05484674
    Brief Title
    Control of Hidradenitis Suppurativa of the Underarms After Combination Deroofing and Laser
    Official Title
    Local Control of Hidradenitis Suppurativa After Combination Deroofing and Long-Pulsed 1064-nm Nd:YAG Laser
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 6, 2022 (Anticipated)
    Primary Completion Date
    August 6, 2023 (Anticipated)
    Study Completion Date
    December 6, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Texas at Austin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to determine whether a series of laser hair removal treatments can improve participant outcomes after deroofing procedures. A deroofing procedure is a surgery where larger hidradenitis suppurativa bumps (called nodules) and hidradenitis suppurativa tunnels (called sinus tracts) are removed and left to heal open without stitches.
    Detailed Description
    Hidradenitis Suppurativa (HS) is a chronic inflammatory disorder characterized by follicular occlusion and rupture which leads to scar and sinus tract formation. Given that medical treatments for HS primarily target inflammation, a multifaceted approach to therapy incorporating procedural techniques is thought to lead to better disease control. Deroofing of nodules and sinus tracts has shown to be beneficial in the treatment of recalcitrant areas that do not respond fully to medical therapy alone. In addition, multiple studies demonstrate the efficacy of long-pulsed 1064-nm Nd:YAG laser in the treatment of HS. To date, no study has evaluated the efficacy of combining surgical deroofing and laser treatment. In this study, participants with Hurley stage II disease of bilateral axillae who meet the study criteria will be treated. Deroofing will be performed to all nodules and sinus tracts in a randomly selected axilla of each participant. Immediately prior to deroofing, participants will have their initial Nd:YAG laser treatment to the selected axilla. Participants will then be treated every four weeks with a series of additional laser treatments. The opposite (untreated) axilla will serve as a control for monitoring baseline disease activity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hidradenitis Suppurativa

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    6 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    One axilla will be treated with deroofing surgery and laser
    Arm Type
    Experimental
    Arm Description
    One axilla will be randomly selected for treatment with deroofing surgery and laser while the other axilla will serve as a control with no treatment for each participant
    Intervention Type
    Procedure
    Intervention Name(s)
    Deroofing and laser
    Intervention Description
    Deroofing and laser to axilla
    Primary Outcome Measure Information:
    Title
    Disease Activity Changes as Assessed by the Hidradenitis Suppurativa Clinical Response
    Description
    The Hidradenitis Suppurativa Clinical Response (HiSCR) is a validated score defined as a 50% or greater reduction in abscesses and inflammatory nodule counts with no increase in abscesses and draining sinus tracts at the end of the study period, as compared to baseline. A participant will be considered either positive, or achieving HiSCR, which indicates that the study intervention significantly improved the participant's disease, or the patient will be negative, or did not achieve HiSCR, indicating that the intervention did not significantly impact the participant's disease. Study researchers will calculate this score based on clinical assessment and lesion counts assessed at the first study visit and the last two study visits. The percent of participants who achieve HiSCR at the last two study visits will be reported.
    Time Frame
    12 months
    Title
    Disease Activity Changes as Assessed by the International Hidradenitis Suppurativa Severity Score System
    Description
    International Hidradenitis Suppurativa Severity Score System (IHS4) changes over the study period will be reported. At each study visit the number of nodules, abscesses, and draining tunnels will be counted in each axilla. The IHS4 score is the number of nodules + abscess count (multiplied by 2) + number of draining tunnels (multiplied by 4). The score can range from 0 lesions and the maximum value is dependent on how many lesions the participant has. The score is used to assess disease severity and can be used to assess how disease severity changes after an intervention. A higher score indicates more active or severe disease, while a lower score indicates less active or less severe disease. Scores throughout the study visits will be reported as well as how these scores change.
    Time Frame
    12 months
    Title
    Disease Recurrence after the Intervention as Assessed by Clinical Exam
    Description
    During study visits, a study team member will count the number of nodules, abscesses, and tunnels in each axilla. A higher count indicates more active or severe disease, whereas a lower count indicates less active or less severe disease. Scores can range from 0 lesions to as many as the participant has. Differences between the counts throughout the study visits will be reported.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Quality of Life Changes as Assessed by the Dermatology Quality of Life Index
    Description
    The Dermatology Life Quality Index (DLQI) tool is a validated questionnaire with 10 questions which asks questions related to activities of daily living and how challenging these are in relation a person's skin disease. Answer choices are either yes or no answers or ratings from "not relevant" or "not at all" to "very much" for each question, regarding how their activities of daily living are affected. Scores range from a minimum of 0 to a maximum of 30 with a higher score indicating a worse quality of life. DLQI surveys will be obtained at the first study visit and the final study visit. Score differences between these two visits will be reported.
    Time Frame
    12 months
    Title
    Pain as assessed by the Visual Analog Scale
    Description
    The Visual Analog Scale is a 10-point validated pain scale which allows a patient to choose a score between 0 to 10 with depictions of faces showing emotions, with 0 being no pain and 10 being the worst possible pain. This questionnaire will be administered at various points throughout the study and changes over time will be reported.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older Diagnosis of hidradenitis suppurativa Hurley stage II with bilateral axillary involvement Must be under the care of a board certified dermatologist and planning to undergo a deroofing procedure of one axilla for the treatment of their HS Disease must be active in the bilateral axillae Activity to be defined as having had at least one flare in the last six months Flare to be defined as patient reported worsening of disease beyond baseline or clinical evidence of active inflammation (i.e. erythema, edema, drainage, tenderness) Exclusion Criteria: Pregnancy Clinical evidence of active superinfection Previous deroofing surgery in any axilla Previous laser therapy in any axilla Patients on the following medical therapies: Any systemic immunomodulating agent that has been started within 3 months of initial deroofing and laser treatment Patients on immunomodulators >3 months with no change in therapy are eligible for participation Use of topical antibiotics, antiseptics, oral antibiotics, oral steroids, intralesional steroids Patients must have stopped all of these agents at least 2 weeks prior to surgical deroofing Use of intramuscular steroids It must be at least 4 weeks since administration of intramuscular steroids before deroofing for a patient to be eligible for participation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Courtney Haller, MD
    Phone
    512-324-9699
    Email
    hsstudy@ascension.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Venessa Pena-Robichaux, MD
    Phone
    512-324-9699
    Email
    venessa.penarobichaux@ascension.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Venessa Pena-Robichaux, MD
    Organizational Affiliation
    Ascension Seton
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Courtney Haller, MD
    Organizational Affiliation
    University of Texas at Austin
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Control of Hidradenitis Suppurativa of the Underarms After Combination Deroofing and Laser

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