What is the mechanism of action of this treatment?

Common treatments for scarring, such as fractional ablative lasers, intense pulsed light (IPL), and fractional radiofrequency, work by creating controlled micro-injuries in the skin. These micro-injuries stimulate the body's natural healing processes, leading to the production of new collagen and elastin fibers. This collagen remodeling and skin regeneration are essential for improving the appearance of scars and enhancing skin texture. For scarring patients, these mechanisms are significant as they offer a promising approach to reduce scar visibility and achieve smoother, healthier skin.

What side effects are associated with this type of intervention?

Common treatments for scarring that promote collagen remodeling and skin regeneration, such as fractionated ablative lasers, can have several side effects. These include local skin irritation, discomfort, erythema (redness), edema (swelling), and potential ulceration. In some cases, there may be a risk of hematoma, bruising, and inflammation. Additionally, treatments like microneedle radiofrequency can cause side effects such as edema and ecchymosis (bruising). It is important to note that while these treatments can be effective, they may also lead to temporary adverse effects that typically resolve with time.

What prior FDA approvals exist?

The FDA has approved several treatments for scarring that involve technologies similar to the Sciton fractionated ablative laser. These include fractional CO2 lasers and erbium lasers, which are known for their ability to promote collagen remodeling and skin regeneration. These treatments work by creating controlled micro-injuries in the skin, stimulating the body's natural healing processes and improving the appearance of scars. Additionally, nonablative lasers and intense pulsed light (IPL) devices have also been approved for treating various types of scars, offering less downtime and a different mechanism of action compared to ablative lasers.

What other types of research exist?

Promising novel alternatives to the Sciton fractionated ablative laser for scarring patients include: 1) Intense Pulsed Light (IPL) therapy, which has shown success in treating various types of scars by promoting collagen production. 2) Fractional Radiofrequency (RF) treatments, which use heat to stimulate collagen remodeling and improve skin texture. 3) Platelet-Rich Plasma (PRP) injections, which leverage growth factors to enhance tissue repair and regeneration. 4) Stem cell therapy, particularly using mesenchymal stem cells (MSCs), which have demonstrated potential in promoting wound healing and reducing scar formation.

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Fractional Ablative Laser

Erbium Laser for Hidradenitis Suppurativa Scarring

N/A

Waitlist Available

Led By Kseniya Kobets, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has an HS PGA (Hidradenitis Suppurativa Physician's Global Assessment) Scale of 0 or 1

Subjects with diagnosis of HS (Hidradenitis Suppurativa) scarring recorded over the past 6 months.

Must not have

History of ongoing pregnancy, active breastfeeding, cancer, and epilepsy.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special laser and creams to treat underarm scars from Hidradenitis Suppurativa. The laser helps the skin heal by making tiny injuries, and the creams improve the skin's appearance. The study aims to see if this treatment can improve patients' quality of life.

Who is the study for?

This trial is for healthy adults over 18 with mild Hidradenitis Suppurativa (HS) scarring in the underarm area. Participants must not smoke, have no recent history of certain scar treatments or surgeries, and cannot be taking specific medications like Accutane. They should not have allergies to lidocaine or a history of keloid scarring.

What is being tested?

The study tests how well an Er: YAG laser treats HS scarring in the armpit region. It's an open-label study where everyone knows they're getting the treatment, and it compares results before and after laser use.

What are the potential side effects?

While side effects are not explicitly listed here, fractional ablative lasers can typically cause redness, swelling, pain at the site of treatment, changes in skin coloration, itching during healing process and potential risk for infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My skin condition is mild or clear according to my doctor.

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I have been diagnosed with HS and have scarring from it in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, and do not have cancer or epilepsy.

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I can safely receive injections with lidocaine and epinephrine.

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I haven't had surgery in the treatment area in the last year or any major surgery in the past 6 months.

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I have not had chemotherapy in the last 12 months and do not have an immune deficiency.

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I haven't taken Accutane, antidepressants, or B-blockers in the last year.

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I have a history of being unusually sensitive to sunlight or have a connective tissue disease.

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I am unable to give consent for the study on my own.

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I do not have uncontrolled diabetes, high blood pressure, or depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Modified Scale for HS Scar Severity (mSHSS)

Secondary study objectives

Physician graded assessment of hyperpigmentation

Physician graded assessment of scar severity

Subject Satisfaction Survey

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Laser TreatmentExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Er: YAG laser

2021

N/A

~30

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for scarring, such as fractional ablative lasers, intense pulsed light (IPL), and fractional radiofrequency, work by creating controlled micro-injuries in the skin. These micro-injuries stimulate the body's natural healing processes, leading to the production of new collagen and elastin fibers. This collagen remodeling and skin regeneration are essential for improving the appearance of scars and enhancing skin texture. For scarring patients, these mechanisms are significant as they offer a promising approach to reduce scar visibility and achieve smoother, healthier skin.

Efficacy of Combined Intense Pulsed Light (IPL) With Fractional CO2 -Laser Ablation in the Treatment of Large Hypertrophic Scars: A Prospective, Randomized Control Trial.