Brief Summary
The goal of this clinical trial is to evaluate the effectiveness of a non-ablative 1470 nm laser in treating scarring alopecia in adults. The study will also investigate the biochemical molecular pathways involved in laser therapy by analyzing hair follicle gene expression before and after laser treatment.
The main questions it aims to answer are:
1. Does a non-ablative laser work to effectively treat scarring alopecia?
2. What molecular pathways are associated with the laser's effects on hair follicles in scarring alopecia?
Participants with scarring alopecia will:
* Receive 3 laser treatments, spaced 1 month apart (Month 1, Month 2, Month 3), and attend 5 follow-up visits (Month 4, Month 6, Month 9, Month 12 and Month 15)
* Have hair follicle samples collected via hair plucking of 10 hairs prior to the start and 1-month post-completion of laser treatments for gene expression analysis of inflammatory and fibrosis pathways implicated in scarring alopecia. Hair samples will be de-identified and kept anonymous.
* Fill out questionnaires at each visit
* Keep a diary of any side effects from laser treatments
The main questions it aims to answer are:
1. Does a non-ablative laser work to effectively treat scarring alopecia?
2. What molecular pathways are associated with the laser's effects on hair follicles in scarring alopecia?
Participants with scarring alopecia will:
* Receive 3 laser treatments, spaced 1 month apart (Month 1, Month 2, Month 3), and attend 5 follow-up visits (Month 4, Month 6, Month 9, Month 12 and Month 15)
* Have hair follicle samples collected via hair plucking of 10 hairs prior to the start and 1-month post-completion of laser treatments for gene expression analysis of inflammatory and fibrosis pathways implicated in scarring alopecia. Hair samples will be de-identified and kept anonymous.
* Fill out questionnaires at each visit
* Keep a diary of any side effects from laser treatments
Brief Title
Non-Ablative Laser to Treat Scarring Alopecia With Hair Follicle Gene Expression Analysis
Detailed Description
This is a prospective, single-center, open-label, baseline-controlled study evaluating the molecular pathways of the effects of a non-ablative 1470 nm laser for the treatment of scarring alopecia. 5 treatment-naive (or at least 1 year since last hair loss medical treatment) participants with prior biopsy-proven or clinically diagnosed scarring alopecia will be enrolled into the study. Hair follicle samples will be obtained via hair plucking prior to the first laser treatment (Month 1) and 1-month post-completion of the laser treatments (Month 4). Each subject will receive 3 laser treatments, spaced 1 month apart, and 5 follow-up visits, planned for Month 4, Month 6, Month 9, Month 12 and Month 15. Measurement outcomes will be compared to baseline.
For this study, the investigators will use the non-ablative Sciton HALO ® laser (1470nm). The non-ablative fractionated treatments with minimal downtime provide synergistic benefit of minimizing tissue damage while improving treatment tolerance and efficiency. The laser works by creating micro-channels in the dermis of the pilosebaceous unit, while leaving bridges of untouched tissue for improved permeability, faster healing, and enhanced delivery of topical treatments. The laser creates controlled zones of coagulation within the dermis. The parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by Sciton and standard of care. Each laser treatment will take approximately 10 to 15 minutes per subject. Pre-treatment procedure will consist of the application of topical anesthetic then cleaning of the affected area of the scalp with antiseptic, either 70% ethanol or 3% hydrogen peroxide. Post-treatment care will follow standard of care. The U.S. Food and Drug Administration (FDA) has cleared the 1470 nm laser for dermatologic purposes. This study will use the laser off-label for the treatment of alopecia. This laser has been approved for the treatment of skin resurfacing; however, research on the use of this laser in alopecia is lacking.
The investigator team plans to define the molecular mechanisms involved in laser treatment of scarring alopecia. Using a non-invasive method of hair plucking, we will evaluate the hair follicle gene expression of inflammatory and fibrosis pathways in participants with scarring alopecia prior to treatment. Changes in gene expression through gene expression analysis of hair follicles at 1-month post-laser treatment completion will also be identified.
The follow up phase will consist of clinical assessments including before and after photographs graded by blinded observers and hair density evaluation using the Canfield HairMetrix ® device. Subjects are instructed to inform clinical staff after the treatment if any adverse events are experienced and will complete patient questionnaires, pain scores, and self-assessments of hair growth.
For this study, the investigators will use the non-ablative Sciton HALO ® laser (1470nm). The non-ablative fractionated treatments with minimal downtime provide synergistic benefit of minimizing tissue damage while improving treatment tolerance and efficiency. The laser works by creating micro-channels in the dermis of the pilosebaceous unit, while leaving bridges of untouched tissue for improved permeability, faster healing, and enhanced delivery of topical treatments. The laser creates controlled zones of coagulation within the dermis. The parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by Sciton and standard of care. Each laser treatment will take approximately 10 to 15 minutes per subject. Pre-treatment procedure will consist of the application of topical anesthetic then cleaning of the affected area of the scalp with antiseptic, either 70% ethanol or 3% hydrogen peroxide. Post-treatment care will follow standard of care. The U.S. Food and Drug Administration (FDA) has cleared the 1470 nm laser for dermatologic purposes. This study will use the laser off-label for the treatment of alopecia. This laser has been approved for the treatment of skin resurfacing; however, research on the use of this laser in alopecia is lacking.
The investigator team plans to define the molecular mechanisms involved in laser treatment of scarring alopecia. Using a non-invasive method of hair plucking, we will evaluate the hair follicle gene expression of inflammatory and fibrosis pathways in participants with scarring alopecia prior to treatment. Changes in gene expression through gene expression analysis of hair follicles at 1-month post-laser treatment completion will also be identified.
The follow up phase will consist of clinical assessments including before and after photographs graded by blinded observers and hair density evaluation using the Canfield HairMetrix ® device. Subjects are instructed to inform clinical staff after the treatment if any adverse events are experienced and will complete patient questionnaires, pain scores, and self-assessments of hair growth.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
618-704-8716
Central Contact Email
ajallorina@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
Scarring Alopecia
Eligibility Criteria
Inclusion Criteria:
* Healthy males and females, at least 18 years of age at time of informed consent, seeking treatment for scarring alopecia
* Subject must be able to read, understand, and voluntarily sign and date an IRB-approved informed consent form
* Subjects with biopsy-proven or clinically diagnosed scarring alopecia recorded within the past 6 months. An established clinical diagnosis will be confirmed by a licensed dermatologist as in previously published hair plucking studies (eg. using trichoscopy and a positive pull test). Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months.
* Subject agrees to not make any changes to their daily hair treatment regimen or start any medications for hair loss such as minoxidil during the study.
* Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated throughout the follow-up period.
Exclusion Criteria:
* Subject does not have capacity to consent to the study
* No ethnic or racial group restrictions
* Subject does not have scarring alopecia
* History of intralesional steroid injections to the scalp in the last 12 months
* Pregnant Women
* Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject.
* Any previous hospitalization or surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
* Allergy or history of prior reaction to lidocaine
* History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy in the prior 12 months.
* Recent COVID-19 infection
* History or current use of the following prescription medications:
* Immunosuppressive medications/biologics, 6 months prior to and during the study
* Accutane or other systemic retinoids within the past twelve months
* Smoking or vaping in the past 12 months.
* History of uncontrolled hyperlipidemia, uncontrolled diabetes mellitus, uncontrolled hepatitis, or uncontrolled bleeding disorders.
* History of major depressive disorders or uncontrolled endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism.
* Healthy males and females, at least 18 years of age at time of informed consent, seeking treatment for scarring alopecia
* Subject must be able to read, understand, and voluntarily sign and date an IRB-approved informed consent form
* Subjects with biopsy-proven or clinically diagnosed scarring alopecia recorded within the past 6 months. An established clinical diagnosis will be confirmed by a licensed dermatologist as in previously published hair plucking studies (eg. using trichoscopy and a positive pull test). Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months.
* Subject agrees to not make any changes to their daily hair treatment regimen or start any medications for hair loss such as minoxidil during the study.
* Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated throughout the follow-up period.
Exclusion Criteria:
* Subject does not have capacity to consent to the study
* No ethnic or racial group restrictions
* Subject does not have scarring alopecia
* History of intralesional steroid injections to the scalp in the last 12 months
* Pregnant Women
* Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject.
* Any previous hospitalization or surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
* Allergy or history of prior reaction to lidocaine
* History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy in the prior 12 months.
* Recent COVID-19 infection
* History or current use of the following prescription medications:
* Immunosuppressive medications/biologics, 6 months prior to and during the study
* Accutane or other systemic retinoids within the past twelve months
* Smoking or vaping in the past 12 months.
* History of uncontrolled hyperlipidemia, uncontrolled diabetes mellitus, uncontrolled hepatitis, or uncontrolled bleeding disorders.
* History of major depressive disorders or uncontrolled endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism.
Inclusion Criteria
Inclusion Criteria:
* Healthy males and females, at least 18 years of age at time of informed consent, seeking treatment for scarring alopecia
* Subject must be able to read, understand, and voluntarily sign and date an IRB-approved informed consent form
* Subjects with biopsy-proven or clinically diagnosed scarring alopecia recorded within the past 6 months. An established clinical diagnosis will be confirmed by a licensed dermatologist as in previously published hair plucking studies (eg. using trichoscopy and a positive pull test). Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months.
* Subject agrees to not make any changes to their daily hair treatment regimen or start any medications for hair loss such as minoxidil during the study.
* Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated throughout the follow-up period.
* Healthy males and females, at least 18 years of age at time of informed consent, seeking treatment for scarring alopecia
* Subject must be able to read, understand, and voluntarily sign and date an IRB-approved informed consent form
* Subjects with biopsy-proven or clinically diagnosed scarring alopecia recorded within the past 6 months. An established clinical diagnosis will be confirmed by a licensed dermatologist as in previously published hair plucking studies (eg. using trichoscopy and a positive pull test). Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months.
* Subject agrees to not make any changes to their daily hair treatment regimen or start any medications for hair loss such as minoxidil during the study.
* Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated throughout the follow-up period.
Gender
All
Gender Based
false
Keywords
alopecia
laser
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06946550
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2025-16805
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
1470 nm Non-Ablative Laser for the Treatment of Scarring Alopecia: A Clinical and Mechanistic Study
Primary Outcomes
Outcome Description
A clinician will answer the following question after evaluating baseline photos and current photos (at each specified point in time).
Please choose the option that better represents the change in hair growth in the treatment area.
The options will be as follows: -3 = Greatly worsened -2 = Moderately worsened -1 = Slightly worsened 0 = No change 1 = Slightly worsened 2 = Moderately improved 3 = Greatly improved. Higher scores will be associated with improved hair growth in treatment area as assessed by a clinician. Group scores will be summarized by each specified point in time.
Please choose the option that better represents the change in hair growth in the treatment area.
The options will be as follows: -3 = Greatly worsened -2 = Moderately worsened -1 = Slightly worsened 0 = No change 1 = Slightly worsened 2 = Moderately improved 3 = Greatly improved. Higher scores will be associated with improved hair growth in treatment area as assessed by a clinician. Group scores will be summarized by each specified point in time.
Outcome Measure
Clinician Global Aesthetic Improvement Scale
Outcome Time Frame
Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15
Outcome Description
Subjects will answer the following questions after evaluating baseline photos and current photos (at each specified point in time).
Please choose the option that better represents the change in hair growth in each treatment area from baseline to today.
The options will be as follows: -3 = Greatly worsened -2 = Moderately worsened -1 = Slightly worsened 0 = No change 1 = Slightly improved 2 = Moderately improved 3 = Greatly improved, such that higher scores are associated with the subjects' self-assessment of improved aesthetic for each assessment. Group scores will be summarized by each specified point in time.
Please choose the option that better represents the change in hair growth in each treatment area from baseline to today.
The options will be as follows: -3 = Greatly worsened -2 = Moderately worsened -1 = Slightly worsened 0 = No change 1 = Slightly improved 2 = Moderately improved 3 = Greatly improved, such that higher scores are associated with the subjects' self-assessment of improved aesthetic for each assessment. Group scores will be summarized by each specified point in time.
Outcome Measure
Subject Global Aesthetic Improvement Scale
Outcome Time Frame
Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15
Outcome Description
Hair density assessed using Canfield HairMetrix imaging device measured as average number of hairs (as reported by the device) per follicular unit for each treatment area (patient-dependent).
Outcome Measure
Hair density
Outcome Time Frame
Baseline/Month 1, 2, 3, 4, 6, 9, 12, 15
Outcome Description
Hair counts assessed using Canfield HairMetrix imaging device measured as average hair count per square centimeter (as reported by the device) per treatment area (patient-dependent).
Outcome Measure
Hair counts
Outcome Time Frame
Baseline/Month 1, 2, 3, 4, 6, 9, 12, 15
Secondary Outcomes
Outcome Description
Comparing baseline photos and current photos of the scalp, the participant will answer the following questions:
1\. Please choose the option that best represents the change in how your hair looks OVERALL in the area treated? 2. Please choose the option that best represents the change in your hair THICKNESS in the area treated? 3. Please choose the option that best represents the change in your hair SHEDDING/LOSS in the area treated? 4. Please choose the option that best represents the change in your hair DARKNESS in the area treated.
The options will be: -3 = Greatly worsened -2 = Moderately worsened -1 = Slightly worsened 0 = No change 1 = Slightly improved 2 = Moderately improved 3 = Greatly improved.
The average values will be reported for each specified point in time for each of the 4 parameters (overall, thickness, shedding/loss, and darkness). Only the first 4 questions of the subject satisfaction questionnaire (as specified above) are considered relevant to the outcome.
1\. Please choose the option that best represents the change in how your hair looks OVERALL in the area treated? 2. Please choose the option that best represents the change in your hair THICKNESS in the area treated? 3. Please choose the option that best represents the change in your hair SHEDDING/LOSS in the area treated? 4. Please choose the option that best represents the change in your hair DARKNESS in the area treated.
The options will be: -3 = Greatly worsened -2 = Moderately worsened -1 = Slightly worsened 0 = No change 1 = Slightly improved 2 = Moderately improved 3 = Greatly improved.
The average values will be reported for each specified point in time for each of the 4 parameters (overall, thickness, shedding/loss, and darkness). Only the first 4 questions of the subject satisfaction questionnaire (as specified above) are considered relevant to the outcome.
Outcome Time Frame
Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15
Outcome Measure
Subject Satisfaction Questionnaire
Outcome Description
The participant will answer a series of 10 questions to measure how much their scarring alopecia has affected their life over the past week. It uses a 10-question self-administered questionnaire where each question is scored from 0 to 3, with a total score ranging from 0 to 30. The change from baseline/Month 1 to the end of the study (Month 15) will be summarized. Positive scores will be indicative of greater impact on the quality of life and negative scores will be indicative of reduced impact on the quality of life.
Outcome Time Frame
From Baseline/Month 1 to Month 15
Outcome Measure
Change in Dermatology Life Quality Index
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kseniya Kobets
Investigator Email
kkobets@montefiore.org
Investigator Phone
718-920-8352
Investigator Department
Medicine
Investigator Division
Dermatology
Investigator Sponsor Organization
Einstein
Study Department
Please Specify
Study Division
Please Specify
Categories Mesh Debug
Skin/Dermatology --- ALOPECIA
MeSH Terms
ALOPECIA
HYPOTRICHOSIS
HAIR DISEASES
SKIN DISEASES
SKIN AND CONNECTIVE TISSUE DISEASES
PATHOLOGICAL CONDITIONS, ANATOMICAL
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS