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

NCT05470322 | Withdrawn DMC FDA Device

• 1 other identifier: 2022-14262
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hidradenitis Suppurativa; Scarring

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Month 6

Secondary Outcomes (18)

• Subject Satisfaction Survey

  Month 1

• Subject Satisfaction Survey

  Month 2

• Subject Satisfaction Survey

  Month 3

• Subject Satisfaction Survey

  Month 4

• Subject Satisfaction Survey

  Month 5

Study Arms (1)

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.

Device: Er: YAG laser

Interventions

Er: YAG laser DEVICE

Patients will be treated with laser for their HS scarring.

Also known as: laser, fractional ablative laser

Laser Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Einstein Advanced Care

Elmsford, New York, 10523, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa; Cicatrix

Interventions

Lasers, Solid-State; 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; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Kseniya Kobets, MD

  Albert Einstein College of Medicine Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking will be performed.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)