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Laser Therapy
Hybrid Fractional Laser for Acne Scars
N/A
Recruiting
Led By Kseniya Kobets, MD
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy males and females, ≥ 18 years of age at time of informed consent, seeking treatment for acne scarring
Subjects with diagnosis of acne scarring recorded over the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 8
Awards & highlights
Study Summary
This trial looks at how well a laser treatment works to reduce acne scars on skin of color.
Who is the study for?
This trial is for adults over 18 with a history of acne scarring who are seeking treatment. Participants must be healthy, non-smokers, and able to follow the study's procedures. They cannot have had any facial surgery in the past year or acne scar treatments in the last six months, nor should they have certain health conditions like major depression, endocrine disorders, or a tendency to form keloid scars.Check my eligibility
What is being tested?
The Sciton Halo laser is being tested for its effectiveness on treating acne scars specifically in people with skin of color. The study will assess how well it works and how tolerable it is for participants.See study design
What are the potential side effects?
Potential side effects may include temporary redness, swelling at the treatment site, changes in skin pigmentation such as lightening or darkening of treated areas (hyperpigmentation), and possibly some discomfort during the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and want treatment for my acne scars.
Select...
I have been diagnosed with acne scarring in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Baseline Patient Satisfaction
Cicatrization
Dermatology Quality of Life Survey
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Hybrid Fractional laser- Non- SOCExperimental Treatment1 Intervention
23 participants with Fitzpatrick skin type I-III will be in this arm. At the first visit, participants will undergo informed consent, education about the procedure, education about proper sun-care, and will be provided sunscreen. Participants will be prescribed a prescription of hydroquinone or a retinol to prevent hyperpigmentation, per standard of care. If participants choose to take this they will wait one month of taking the prescription and then begin treatment sessions. If not, participants can begin treatment sessions right away. Treatment consists of 3 laser sessions with the Sciton Halo hybrid fractional laser. Session amount depends on the degree of improvement. At each session before and after images will be collected. At each session participants will fill out the dermatology quality of life survey as well as a patient satisfaction survey.
Group II: Hybrid Fractional laser - SOCExperimental Treatment1 Intervention
23 participants with fitzpatrick skin type IV-V will be in this arm. At the first visit, participants will undergo informed consent, education about the procedure, education about proper sun-care, and will be provided sunscreen. Participants will be prescribed a prescription of hydroquinone or a retinol to prevent hyperpigmentation, per standard of care. If participants choose to take this they will wait one month of taking the prescription and then begin treatment sessions. If not, participants can begin treatment sessions right away. Treatment consists of 3 laser sessions with the Sciton Halo hybrid fractional laser. Session amount depends on the degree of improvement. At each session before and after images will be collected. At each session participants will fill out the dermatology quality of life survey as well as a patient satisfaction survey.
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Who is running the clinical trial?
Albert Einstein College of MedicineLead Sponsor
287 Previous Clinical Trials
11,857,062 Total Patients Enrolled
Kseniya Kobets, MDPrincipal InvestigatorMontefiore Medical Center
4 Previous Clinical Trials
29 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had acne scar treatments in the last 6 months.I am willing and able to follow the treatment and check-up schedule.I am over 18 and want treatment for my acne scars.I am unable to give consent for the study on my own.I have not had chemotherapy in the last 12 months and do not have an immune deficiency.I have a history of depression or thyroid problems.You are in good health and do not smoke.I have a history of high cholesterol, diabetes, hepatitis, or bleeding disorders.I have been diagnosed with acne scarring in the last 6 months.I am not pregnant, breastfeeding, and do not have cancer or epilepsy.I have a history of being unusually sensitive to sunlight or have a connective tissue disease.I have had severe acne in the last 6 months.I haven't taken immunosuppressants or retinoids in the past 6-12 months.I haven't had surgery in the treatment area in the past year or any major surgery in the last 6 months.You have smoked or vaped in the last 12 months.You have a history of keloid scars.
Research Study Groups:
This trial has the following groups:- Group 1: Hybrid Fractional laser - SOC
- Group 2: Hybrid Fractional laser- Non- SOC
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.
What is the maximum capacity of participants in this research endeavor?
"Affirmative. Clinicaltrials.gov data verifies that this clinical study, which was first shared on September 1st 2023 is now recruiting patients. Approximately 46 individuals need to be enrolled from one medical centre."
Answered by AI
Are there still opportunities to partake in this medical research?
"Affirmative. According to clinicaltrials.gov, this medical trial is in the process of recruiting participants; initial posting was September 1st 2023 and it has since been updated on August 17th 2023. There are 46 patients that need to be sourced from a single centre."
Answered by AI
Who else is applying?
What site did they apply to?
555 Taxter Road
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I’ve been struggling with the appearance of my skin. My acne scars really take a huge toll on my confidence. I’m hoping the trial can help improve the look of my scars.
PatientReceived 1 prior treatment
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