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

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Hydrocortisone; Hydroquinone; Tretinoin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.