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

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Hidradenitis Suppurativa

Treatments: Procedure: Deroofing and laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05484674

STUDY00000679

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

One axilla will be treated with deroofing surgery and laser

Experimental group

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

Treatment:

Procedure: Deroofing and laser