Hidradenitis SuppurativaNCT05484674
Control of Hidradenitis Suppurativa of the Underarms After Combination Deroofing and Laser
A study testing Deroofing and laser in people with Hidradenitis Suppurativa, run by University of Texas at Austin.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Deroofing and laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 6 Aug 2022to 6 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Local Control of Hidradenitis Suppurativa After Combination Deroofing and Long-Pulsed 1064-nm Nd:YAG Laser
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.
Read the 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Deroofing and laser
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deroofing and laserProcedure or surgery
Deroofing and laser to axilla
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Deroofing and laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start6 Aug 2022 (estimated)
- Primary completion6 Aug 2023 (estimated)
- Study completion6 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Venessa Pena-Robichaux, MD, Principal investigator, Ascension SetonCourtney Haller, MD, Study director, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484674
- Sponsor's protocol ID
- STUDY00000679
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Control of Hidradenitis Suppurativa After Combination Deroofing and Long-Pulsed 1064-nm Nd:YAG Laser
- ClinicalTrials.gov ID
- NCT05484674
- Acronym / sponsor ID
- STUDY00000679
- Conditions
- Hidradenitis Suppurativa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 6 Aug 2022 (estimated)
- Primary completion
- 6 Aug 2023 (estimated)
- Study completion
- 6 Dec 2023 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One axilla will be treated with deroofing surgery and laser | Experimental | Procedure: Deroofing and laserOne 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Pregnancy
- Clinical evidence of active superinfection
- Previous deroofing surgery in any axilla
- Previous laser therapy in any axilla
- Patients on the following medical therapies:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deroofing and laserDeroofing and laser to axilla | Procedure or surgery | One axilla will be treated with deroofing surgery and laser |
Primary outcome
Disease Activity Changes as Assessed by the Hidradenitis Suppurativa Clinical Response
Time frame: 12 months
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.
Disease Activity Changes as Assessed by the International Hidradenitis Suppurativa Severity Score System
Time frame: 12 months
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.
Disease Recurrence after the Intervention as Assessed by Clinical Exam
Time frame: 12 months
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.
2 secondary outcomes
Quality of Life Changes as Assessed by the Dermatology Quality of Life Index
Time frame: 12 months
Pain as assessed by the Visual Analog Scale
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venessa Pena-Robichaux, MD principal investigator
Ascension Seton
Courtney Haller, MD study director
University of Texas at Austin
Questions about this trial
What is this clinical trial studying?
A study testing Deroofing and laser in people with Hidradenitis Suppurativa, run by University of Texas at Austin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Courtney Haller, MD (512-324-9699, hsstudy@ascension.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity Changes as Assessed by the Hidradenitis Suppurativa Clinical Response (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.