Clinical trial NCT05484674: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hidradenitis Suppurativa
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disease Activity Changes as Assessed by the Hidradenitis Suppurativa Clinical Response
timeFrame: 12 months
measure: Disease Activity Changes as Assessed by the International Hidradenitis Suppurativa Severity Score System
timeFrame: 12 months
measure: Disease Recurrence after the Intervention as Assessed by Clinical Exam
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life Changes as Assessed by the Dermatology Quality of Life Index
timeFrame: 12 months
measure: Pain as assessed by the Visual Analog Scale
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Ascension Seton
name: Venessa Pena-Robichaux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas at Austin
name: Courtney Haller, MD
role: STUDY_DIRECTOR
References: