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Nonablative Laser
Laser Therapy for Male Pattern Baldness and Scarring Alopecia
N/A
Recruiting
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
Subjects with diagnosis of biopsy proven androgenetic alopecia or scarring alopecia with hair loss recorded over the past 6 months
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 15
Awards & highlights
Study Summary
This trialtested a laser to treat two types of hair loss: androgenetic & scarring alopecia.
Who is the study for?
This trial is for healthy adults over 18 with a confirmed diagnosis of androgenetic alopecia or scarring alopecia, who have experienced hair loss in the last 6 months. Participants must not smoke, should agree to maintain their current hair care routine without changes, and cannot have used certain hair loss treatments recently.Check my eligibility
What is being tested?
The study tests a non-ablative 1470 nm laser (Sciton HALO) on individuals with specific types of hair loss. It's an open-label pilot study where all participants receive the same treatment to see if it improves their condition.See study design
What are the potential side effects?
While specific side effects are not listed here, similar laser treatments may cause skin irritation, redness, swelling at the treatment site, and potential changes in skin pigmentation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of hair loss due to genetics or scarring in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hair counts
Hair density
Live and Photographic assessment of hair loss
Secondary outcome measures
Subject Satisfaction
Subject Satisfation
Trial Design
2Treatment groups
Experimental Treatment
Group I: Scarring AlopeciaExperimental 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 scarring alopecia.
Group II: Androgenetic AlopeciaExperimental 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 androgenetic alopecia.
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Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,186 Total Patients Enrolled
ScitonIndustry Sponsor
18 Previous Clinical Trials
1,301 Total Patients Enrolled
Kseniya Kobets, MDPrincipal InvestigatorAlbert Einstein College of Medicine Montefiore Medical Center
4 Previous Clinical Trials
65 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken immunosuppressive drugs in the last 6 months.I am 18 or older and looking for treatment for hair loss.I am over 18 and looking for treatment for hair loss.I am willing and able to follow the treatment and check-up schedule.I have a history of major depression or thyroid problems.I am willing and able to follow the treatment and check-up schedule.I have not had steroid injections in my scalp in the past year.I haven't had surgery in the treatment area in the last year or any major surgery in the last 6 months.I have a history of high cholesterol, diabetes, hepatitis, or bleeding disorders.I have not used Accutane or similar medications in the last year.I have a type of hair loss condition affecting my scalp.You are allergic to or had a bad reaction to lidocaine before.You have smoked or vaped in the last 12 months.I am unable to give consent for the study on my own.I haven't used minoxidil or drugs like finasteride in the last 3 months.I have not had chemotherapy in the last 12 months and do not have an immune deficiency.I have been diagnosed with a type of hair loss due to genetics or scarring in the last 6 months.You are a healthy non-smoker who agrees not to make any changes to their daily hair treatment regime during the study.You have a medical condition that the doctor thinks might make you more likely to have a reaction to sunlight.
Research Study Groups:
This trial has the following groups:- Group 1: Androgenetic Alopecia
- Group 2: Scarring Alopecia
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.
Male Pattern Baldness Patient Testimony for trial: Trial Name: NCT05460611 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers still enrolling participants for this experiment?
"This trial is currently in search of participants, as evidenced by information on clinicaltrials.gov. It was first advertised on January 1st 2023 and has since been updated to reflect new developments occurring around December 15th 2022."
Answered by AI
How many participants are currently signed up for this trial?
"Affirmative. The information on clinicaltrials.gov clarifies that this experiment, which was initially made public on January 1st 2023, is still seeking participants. 10 individuals need to be brought into the trial at one particular medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
New Jersey
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0
What site did they apply to?
Montefiore Einstein Advanced Care
What questions have other patients asked about this trial?
Do you accept patients from abroad?
PatientReceived no prior treatments
Why did patients apply to this trial?
There are no known cures for scarring alopecia in New Zealand. I have tried finasteride, minoxidil and a derma roller previously with little success. The pace of hair loss seems to have increased in the last few years and I was thinking of ways to reverse it. Taking part in a clinical trial is probably my best bet at this point, but they are hard to find which is why I am willing to travel to be involved.
PatientReceived 1 prior treatment
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