Hidradenitis SuppurativaNCT05470322

Efficacy and Tolerability of a Fractional Ablative Erbium Laser for Axillary Scarring for Hidradenitis Suppurativa Patients

A study testing Er: YAG laser in people with Hidradenitis Suppurativa and Scarring, run by Montefiore Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Single center, open-label, baseline-controlled study evaluating the use of a Sciton fractionated ablative laser in the treatment of Hidradenitis Suppurativa (HS) scarring. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hidradenitis Suppurativa, Scarring
What is being tested?: Er: YAG laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Jan 2026to Jul 2027
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy males and females, ≥ 18 years of age at time of informed consent with no upper age limit, seeking treatment for HS scarring in the axillary region.
Subjects must voluntarily sign and date an IRB approved informed consent form.
Subjects with diagnosis of HS (Hidradenitis Suppurativa) scarring recorded over the past 6 months.
Subject has an HS PGA (Hidradenitis Suppurativa Physician's Global Assessment) Scale of 0 or 1
Able to read, understand and voluntarily provide written informed consent.
Subjects are determined to be healthy, non-smokers.
Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
Understand and accept the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.

Who cannot join

Subject does not have the capacity to consent to the study.
Subject underwent any medical-grade scar treatments (ie, lasers, excision procedures, topical prescriptions for scars) in the past 6 months prior to enrollment in the study.
Any history of keloid scarring.
Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy for prior 12 months.
Subject has no health contraindications to receiving local lidocaine and epinephrine injections, including but not limited to any form of heart disease or arrhythmia, untreated or uncontrolled severe hypertension, uncontrolled hyperthyroidism, uncontrolled diabetes, pheochromocytoma, Cocaine use.

Show all 12Show fewer

History or current use of the following prescription medications:Accutane or other systemic retinoids within the past twelve months, Tricyclic antidepressant, monoamine oxidase inhibitors, B-blocker
Smoking or vaping in the past 12 months.
History of an allergy or an adverse reaction to hydroquinone or tretinoin.
History of photosensitivity and/or connective tissue disease.
History of uncontrolled diabetes, hypertension and depression.
History of ongoing pregnancy, active breastfeeding, cancer, and epilepsy.

Trial locations and contacts

1 site in 1 country.

United States1 site

Montefiore Einstein Advanced Care
Elmsford, New York, 10523

Other trials in United States

About this study

Single center, open-label, baseline-controlled study evaluating the use of a Sciton fractionated ablative laser in the treatment of Hidradenitis Suppurativa (HS) scarring.

Read the detailed description

Single center, open-label, baseline-controlled study evaluating the use of a Sciton fractionated ablative laser in the treatment of Hidradenitis Suppurativa (HS) scarring. The device is FDA approved for the treatment of scarring in all skin types. The study team seeks to observe the efficacy and tolerability in patients without active HS lesions. The study may enroll up to 19 subjects looking for improvement in their HS scarring in the axillary region. The subjects will receive treatment with the Sciton Joule Er:YAG 2940nm laser along with treatment with topical tretinoin, hydroquinone, and hydrocortisone starting 1 month prior to first laser treatment as per standard of care for scar treatment. Each patient will receive 3 treatments spaced approximately one month apart. The patients will be surveyed about their quality of life due to HS scarring, as well as their perspectives on their axillary scarring before and after their assigned treatments. All patients included in the study will have no contraindications to either laser or the use of standard treatment protocol (tretinoin and hydroquinone). Subjects in the laser group will complete a DLQI (Dermatology Life Quality Index) survey, patient satisfaction survey, and clinical photographs at each treatment visit and at follow-up 1, 2, and 3 months after the last treatment. Subjects in the topical treatment group will be evaluated at the initial visit, month 3 and month 6.

Conditions: Hidradenitis Suppurativa, Scarring
Being tested: Er: YAG laser
Medical subject headings: Hidradenitis Suppurativa, Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Er: YAG laserDevice
Also called laser, fractional ablative laser
Patients will be treated with laser for their HS scarring.

Study groups in NCT05470322
Study group	Role	What they receive
Laser Treatment	Experimental	The parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by Sciton. Each laser treatment will take approximately 10 to 15 minutes per subject to target HS scarring. Receives: Device: Er: YAG laser

What is being measured

The primary outcome is the main question the study is designed to answer.

Modified Scale for HS Scar Severity (mSHSS)
HS Scar Severity will be assessed in participants using mSHSS as follows:
Clear - 0 - No visible scars from HS Almost Clear -1 - Hardly visible from 2.5 m away Mild - 2-Easily recognizable; less than half the affected area Moderate - 3 - More than half the affected area involved Severe - 4 - Entire area involved Very Severe - 5 - Entire area with prominent atrophic or hypertrophic scars
Measured: Month 0
Modified Scale for HS Scar Severity (mSHSS)
HS Scar Severity will be assessed in participants using mSHSS as follows:
Clear - 0 - No visible scars from HS Almost Clear -1 - Hardly visible from 2.5 m away Mild - 2-Easily recognizable; less than half the affected area Moderate - 3 - More than half the affected area involved Severe - 4 - Entire area involved Very Severe - 5 - Entire area with prominent atrophic or hypertrophic scars
Measured: Month 6

Secondary outcomes (18)

Subject Satisfaction Survey
Following treatment participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Measured: Month 1
Subject Satisfaction Survey
Following treatment participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Measured: Month 2
Subject Satisfaction Survey
Following treatment participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Measured: Month 3
Subject Satisfaction Survey
Participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Measured: Month 4
Subject Satisfaction Survey
Participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Measured: Month 5
Subject Satisfaction Survey
Participants will be asked to complete a survey in the clinic while referring to their image in a mirror and comparing post-treatment photos versus baseline photos. Scoring will be assessed as follows (-3 = Greatly decreased, -2 = Moderately decreased, -1 = Slightly decreased, 0 = No change, 1 = Slightly increased, 2 = Moderately increased, 3 = Greatly increased) with a lower overall score denoting improvement in appearance.
Measured: Month 6
Physician graded assessment of scar severity
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Measured: Month 0
Physician graded assessment of hyperpigmentation
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Measured: Month 0
Physician graded assessment of scar severity
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Measured: Month 2
Physician graded assessment of hyperpigmentation
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Measured: Month 2
Physician graded assessment of scar severity
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Measured: Month 3
Physician graded assessment of hyperpigmentation
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Measured: Month 3
Physician graded assessment of scar severity
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Measured: Month 4
Physician graded assessment of hyperpigmentation
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Measured: Month 4
Physician graded assessment of scar severity
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Measured: Month 5
Physician graded assessment of hyperpigmentation
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Measured: Month 5
Physician graded assessment of hyperpigmentation
Hyperpigmentation will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened hyperpigmentation) to 3 (greatly improved hyperpigmentation). A score of zero represents no change in hyperpigmentation.
Measured: Month 6
Physician graded assessment of scar severity
Scar severity will be assessed in participants by way of GAIS (Global Aesthetic Improvement Scale) using photographic assessments. Scoring will range from -3 (greatly worsened scar severity) to 3 (greatly improved scar severity). A score of zero represents no change in scar severity.
Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2026Jul 2027

First posted22 Jul 2022
Study startJan 2026 (estimated)
Primary completionJul 2027 (estimated)
Study completionJul 2027 (estimated)

Why it stopped: No patients were able to consented/enrolled into the study during the period of time the study was approved by the IRB. Study officially withdrawn with the IRB on 11/24/2025.

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 Montefiore Medical CenterThe 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: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05470322
Sponsor's protocol ID: 2022-14262
Status last verified: Dec 2025
First submitted: 20 Jul 2022
Last updated: 17 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)

All Hidradenitis Suppurativa trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Tolerability of a Fractional Ablative Erbium Laser for Axillary Scarring for Hidradenitis Suppurativa Patients
ClinicalTrials.gov ID: NCT05470322
Acronym / sponsor ID: 2022-14262
Conditions: Hidradenitis Suppurativa, Scarring
Study type: Interventional
Recruitment status: WithdrawnReason stopped: No patients were able to consented/enrolled into the study during the period of time the study was approved by the IRB. Study officially withdrawn with the IRB on 11/24/2025.
Enrolment: 0 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Study start: Jan 2026 (estimated)
Primary completion: Jul 2027 (estimated)
Study completion: Jul 2027 (estimated)
First posted: 22 Jul 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.

Single center, open-label, baseline-controlled study evaluating the use of a Sciton fractionated ablative laser in the treatment of Hidradenitis Suppurativa (HS) scarring.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Laser Treatment	Experimental	Device: Er: YAG laserThe parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by Sciton. Each laser treatment will take approximately 10 to 15 minutes per subject to target HS scarring.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Healthy males and females, ≥ 18 years of age at time of informed consent with no upper age limit, seeking treatment for HS scarring in the axillary region.
Subjects must voluntarily sign and date an IRB approved informed consent form.
Subjects with diagnosis of HS (Hidradenitis Suppurativa) scarring recorded over the past 6 months.
Subject has an HS PGA (Hidradenitis Suppurativa Physician's Global Assessment) Scale of 0 or 1
Able to read, understand and voluntarily provide written informed consent.

Key exclusion criteria (12 listed)

Subject does not have the capacity to consent to the study.
Subject underwent any medical-grade scar treatments (ie, lasers, excision procedures, topical prescriptions for scars) in the past 6 months prior to enrollment in the study.
Any history of keloid scarring.
Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy for prior 12 months.

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
Er: YAG laserAlso: laser, fractional ablative laserPatients will be treated with laser for their HS scarring.	Device	Laser Treatment

Primary outcome

Modified Scale for HS Scar Severity (mSHSS)
Time frame: Month 0
HS Scar Severity will be assessed in participants using mSHSS as follows: Clear - 0 - No visible scars from HS Almost Clear -1 - Hardly visible from 2.5 m away Mild - 2-Easily recognizable; less than half the affected area Moderate - 3 - More than half the affected area involved Severe - 4 - Entire area involved Very Severe - 5 - Entire area with prominent atrophic or hypertrophic scars
Modified Scale for HS Scar Severity (mSHSS)
Time frame: Month 6
HS Scar Severity will be assessed in participants using mSHSS as follows: Clear - 0 - No visible scars from HS Almost Clear -1 - Hardly visible from 2.5 m away Mild - 2-Easily recognizable; less than half the affected area Moderate - 3 - More than half the affected area involved Severe - 4 - Entire area involved Very Severe - 5 - Entire area with prominent atrophic or hypertrophic scars

18 secondary outcomes

Subject Satisfaction Survey
Time frame: Month 1
Subject Satisfaction Survey
Time frame: Month 2
Subject Satisfaction Survey
Time frame: Month 3
Subject Satisfaction Survey
Time frame: Month 4
Subject Satisfaction Survey
Time frame: Month 5
Subject Satisfaction Survey
Time frame: Month 6
Physician graded assessment of scar severity
Time frame: Month 0
Physician graded assessment of hyperpigmentation
Time frame: Month 0
Physician graded assessment of scar severity
Time frame: Month 2
Physician graded assessment of hyperpigmentation
Time frame: Month 2
Physician graded assessment of scar severity
Time frame: Month 3
Physician graded assessment of hyperpigmentation
Time frame: Month 3
Physician graded assessment of scar severity
Time frame: Month 4
Physician graded assessment of hyperpigmentation
Time frame: Month 4
Physician graded assessment of scar severity
Time frame: Month 5
Physician graded assessment of hyperpigmentation
Time frame: Month 5
Physician graded assessment of hyperpigmentation
Time frame: Month 6
Physician graded assessment of scar severity
Time frame: Month 6

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
Individual participant dataSharing planned: No

Related trials for Hidradenitis Suppurativa

Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)

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.

Kseniya Kobets, MD principal investigator

Albert Einstein College of Medicine Montefiore Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Er: YAG laser in people with Hidradenitis Suppurativa and Scarring, run by Montefiore Medical Center at 1 site in United States.

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 8 inclusion and 12 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: withdrawn, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Scale for HS Scar Severity (mSHSS) (time frame: Month 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05470322.

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 17 Dec 2025.