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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.
Full 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.
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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
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
Use of topical antibiotics, antiseptics, oral antibiotics, oral steroids, intralesional steroids
Use of intramuscular steroids
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
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Central trial contact
Venessa Pena-Robichaux, MD; Courtney Haller, MD
Data sourced from clinicaltrials.gov
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