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

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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

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.
    


Study Type

Interventional


Primary Outcome

Disease Activity Changes as Assessed by the Hidradenitis Suppurativa Clinical Response

Secondary Outcome

 Quality of Life Changes as Assessed by the Dermatology Quality of Life Index

Condition

Hidradenitis Suppurativa

Intervention

Deroofing and laser

Study Arms / Comparison Groups

 One axilla will be treated with deroofing surgery and laser
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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

6

Start Date

August 6, 2022

Completion Date

December 6, 2023

Primary Completion Date

August 6, 2023

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Venessa Pena-Robichaux, MD, 512-324-9699, [email protected]



Administrative Informations


NCT ID

NCT05484674

Organization ID

STUDY00000679


Responsible Party

Sponsor

Study Sponsor

University of Texas at Austin


Study Sponsor

Venessa Pena-Robichaux, MD, Principal Investigator, Ascension Seton


Verification Date

July 2022