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

NCT05484674 | Unknown

• 1 other identifier: STUDY00000679
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (3)

• 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.

  12 months

• 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.

  12 months

• 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.

  12 months

Secondary Outcomes (2)

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

  12 months

• Pain as assessed by the Visual Analog Scale

  12 months

Study Arms (1)

One axilla will be treated with deroofing surgery and laser

EXPERIMENTAL

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

Procedure: Deroofing and laser

Interventions

Deroofing and laser PROCEDURE

Deroofing and laser to axilla

One axilla will be treated with deroofing surgery and laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Lasers

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Venessa Pena-Robichaux, MD

  Ascension Seton

  PRINCIPAL INVESTIGATOR

• Courtney Haller, MD

  University of Texas at Austin

  STUDY DIRECTOR

Central Study Contacts

Courtney Haller, MD

CONTACT

512-324-9699; hsstudy@ascension.org

Venessa Pena-Robichaux, MD

CONTACT

512-324-9699; venessa.penarobichaux@ascension.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: August 2, 2022
• Study Start: August 6, 2022
• Primary Completion: August 6, 2023
• Study Completion: December 6, 2023
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share