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

Hidradenitis Suppurativa Clinical Trial

Official title:

Local Control of Hidradenitis Suppurativa After Combination Deroofing and Long-Pulsed 1064-nm Nd:YAG Laser

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05484674
• Other study ID #: STUDY00000679
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 6, 2022
• Est. completion date: December 6, 2023

Study information

• Verified date: July 2022
• Source: University of Texas at Austin
• Contact: Courtney Haller, MD
• Phone: 512-324-9699
• Email: hsstudy[@]ascension.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: December 6, 2023
• Est. primary completion date: August 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Procedure:
• Deroofing and laser
Deroofing and laser to axilla

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Quality of Life Changes as Assessed by the Dermatology Quality of Life Index	The Dermatology Life Quality Index (DLQI) tool is a validated questionnaire with 10 questions which asks questions related to activities of daily living and how challenging these are in relation a person's skin disease. Answer choices are either yes or no answers or ratings from "not relevant" or "not at all" to "very much" for each question, regarding how their activities of daily living are affected. Scores range from a minimum of 0 to a maximum of 30 with a higher score indicating a worse quality of life. DLQI surveys will be obtained at the first study visit and the final study visit. Score differences between these two visits will be reported.	12 months
Secondary	Pain as assessed by the Visual Analog Scale	The Visual Analog Scale is a 10-point validated pain scale which allows a patient to choose a score between 0 to 10 with depictions of faces showing emotions, with 0 being no pain and 10 being the worst possible pain. This questionnaire will be administered at various points throughout the study and changes over time will be reported.	12 months