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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights
Study Summary
This trial looks at how using a laser can reduce scarring from HS, a chronic skin condition.
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.Check my eligibility
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.See study design
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 belowSelect...
My skin condition is mild or clear according to my doctor.
Select...
I have been diagnosed with HS and have scarring from it in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Modified Scale for HS Scar Severity (mSHSS)
Secondary outcome measures
Physician graded assessment of hyperpigmentation
Physician graded assessment of scar severity
Subject Satisfaction Survey
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
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,177 Total Patients Enrolled
Kseniya Kobets, MDPrincipal InvestigatorAlbert Einstein College of Medicine Montefiore Medical Center
4 Previous Clinical Trials
56 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the treatment and check-up plan.I am not pregnant, breastfeeding, and do not have cancer or epilepsy.I can safely receive injections with lidocaine and epinephrine.I have not had chemotherapy in the last 12 months and do not have an immune deficiency.I have not had any treatments for scars in the last 6 months.I haven't had surgery in the treatment area in the last year or any major surgery in the past 6 months.I haven't taken Accutane, antidepressants, or B-blockers in the last year.You have had a bad reaction to hydroquinone or tretinoin in the past.I have a history of being unusually sensitive to sunlight or have a connective tissue disease.My skin condition is mild or clear according to my doctor.I am unable to give consent for the study on my own.You have smoked or vaped in the last 12 months.I am over 18 and seeking treatment for HS scarring under my arms.You have had keloid scars in the past.I do not have uncontrolled diabetes, high blood pressure, or depression.I have been diagnosed with HS and have scarring from it in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Laser Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for individuals to join this research initiative?
"Affirmative. Clinicaltrials.gov data suggests that this clinical trial, incepted on June 1st 2023, is actively seeking participants. 19 patients are being recruited from a single medical site."
Answered by AI
How many participants have been engaged in this research endeavor?
"Indeed, the data hosted on clinicaltrials.gov verifies that this research project is enlisting members. This study was published on June 1st 2023 and was recently modified on June 13th 2023. The investigation seeks to recruit 19 patients from a single site."
Answered by AI
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