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

Last updated: April 13, 2025
Sponsor: Montefiore Medical Center
Overall Status: Suspended

Phase

N/A

Condition

Hidradenitis Suppurativa

Scar Tissue

Scalp Disorders

Treatment

Er: YAG laser

Clinical Study ID

NCT05470322
2022-14262
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy males and females, ≥ 18 years of age at time of informed consent with noupper 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 thepast 6 months.

  • Subject has an HS PGA (Hidradenitis Suppurativa Physician's Global Assessment) Scaleof 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-upschedule and requirements.

  • Understand and accept the obligation not to undergo any other procedures in theareas to be treated through the follow-up period.

Exclusion

Exclusion Criteria:

  • Subject does not have the capacity to consent to the study.

  • Subject underwent any medical-grade scar treatments (ie, lasers, excisionprocedures, topical prescriptions for scars) in the past 6 months prior toenrollment in the study.

  • Any history of keloid scarring.

  • Any previous surgical procedure in the treatment area in the past 12 months, ormajor surgery in the last 6 months.

  • History of immunosuppression/immune deficiency disorders (including AIDS and HIVinfection), and/or any history of systemic chemotherapy for prior 12 months.

  • Subject has no health contraindications to receiving local lidocaine and epinephrineinjections, 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 othersystemic 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.

Study Design

Total Participants: 19
Treatment Group(s): 1
Primary Treatment: Er: YAG laser
Phase:
Study Start date:
January 01, 2026
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • Montefiore Einstein Advanced Care

    Elmsford, New York 10523
    United States

    Site Not Available

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