Scarring AlopeciaNCT06946550
Non-Ablative Laser to Treat Scarring Alopecia With Hair Follicle Gene Expression Analysis
A study testing 1470nm non-ablative fractional laser in people with Scarring Alopecia, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scarring Alopecia
- What is being tested?
- 1470nm non-ablative fractional laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Einstein Advanced Care
Elmsford, New York, 10523
Anika Jallorina, 914-457-4130, ajallorina@montefiore.org
Kseniya Kobets, MD
About this study
Official title: 1470 nm Non-Ablative Laser for the Treatment of Scarring Alopecia: A Clinical and Mechanistic Study
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:
Read more
- Does a non-ablative laser work to effectively treat scarring alopecia?
- 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
Read the 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.
- Conditions
- Scarring Alopecia
- Being tested
- 1470nm non-ablative fractional laser
- Keywords
- alopecia, laser
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1470nm non-ablative fractional laserDevice
Patients with scarring alopecia will be treated with the non-ablative Sciton HALO laser (1470nm).
| Study group | Role | What they receive |
|---|---|---|
| Scarring alopecia | Experimental | Patients with scarring alopecia will receive 3 treatments with the non-ablative Sciton HALO laser (1470nm). Each laser treatment will take approximately 10 to 15 minutes per subject. Receives: Device: 1470nm non-ablative fractional laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Global Aesthetic Improvement Scale
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.
Measured: Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15
Subject Global Aesthetic Improvement Scale
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.
Measured: Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15
Hair density
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).
Measured: Baseline/Month 1, 2, 3, 4, 6, 9, 12, 15
Hair counts
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).
Measured: Baseline/Month 1, 2, 3, 4, 6, 9, 12, 15
Secondary outcomes (2)
Subject Satisfaction Questionnaire
Comparing baseline photos and current photos of the scalp, the participant will answer the following questions:
- 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.
Measured: Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15
Change in Dermatology Life Quality Index
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.
Measured: From Baseline/Month 1 to Month 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start9 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Scarring AlopeciaStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sciton, American Society for Laser Surgery and Medicine
- Responsible party
- Sponsor
- Investigators
- Kseniya Kobets, MD, Principal investigator, Albert Einstein College of Medicine Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946550
- Sponsor's protocol ID
- 2025-16805
- Other IDs
- 2025
- Status last verified
- Dec 2025
- First submitted
- 19 Apr 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Karnik P, Tekeste Z, McCormick TS, Gilliam AC, Price VH, Cooper KD, Mirmirani P. Hair follicle stem cell-specific PPARgamma deletion causes scarring alopecia. J Invest Dermatol. 2009 May;129(5):1243-57. doi: 10.1038/jid.2008.369. Epub 2008 Dec 4.
PubMed 19052558Anzai A, Wang EHC, Lee EY, Aoki V, Christiano AM. Pathomechanisms of immune-mediated alopecia. Int Immunol. 2019 Jul 13;31(7):439-447. doi: 10.1093/intimm/dxz039.
PubMed 31050755Hordinsky M. Scarring Alopecia: Diagnosis and New Treatment Options. Dermatol Clin. 2021 Jul;39(3):383-388. doi: 10.1016/j.det.2021.05.001.
PubMed 34053592Van Mater D, Kolligs FT, Dlugosz AA, Fearon ER. Transient activation of beta -catenin signaling in cutaneous keratinocytes is sufficient to trigger the active growth phase of the hair cycle in mice. Genes Dev. 2003 May 15;17(10):1219-24. doi: 10.1101/gad.1076103.
PubMed 12756226Jamerson TA, Conover Talbot C Jr, Dina Y, Kwatra SG, Garza LA, Aguh C. Gene expression profiling suggests severe, extensive central centrifugal cicatricial alopecia may be both clinically and biologically distinct from limited disease subtypes. Exp Dermatol. 2022 May;31(5):789-793. doi: 10.1111/exd.14524. Epub 2022 Jan 20.
PubMed 35007355Tanakol A, Oba MC, Uzuncakmak TK, Askin O, Kutlubay Z. Treatment of alopecia areata with 2940-nm fractional erbium:yttrium-aluminum-garnet laser. Dermatol Ther. 2020 Nov;33(6):e13978. doi: 10.1111/dth.13978. Epub 2020 Aug 6.
PubMed 32633447Cho SB, Goo BL, Zheng Z, Yoo KH, Kang JS, Kim H. Therapeutic efficacy and safety of a 1927-nm fractionated thulium laser on pattern hair loss: an evaluator-blinded, split-scalp study. Lasers Med Sci. 2018 May;33(4):851-859. doi: 10.1007/s10103-018-2437-5. Epub 2018 Jan 16.
PubMed 29340854Ke J, Guan H, Li S, Xu L, Zhang L, Yan Y. Erbium: YAG laser (2,940 nm) treatment stimulates hair growth through upregulating Wnt 10b and beta-catenin expression in C57BL/6 mice. Int J Clin Exp Med. 2015 Nov 15;8(11):20883-9. eCollection 2015.
PubMed 26885014Raffi J, Suresh R, Agbai O. Clinical recognition and management of alopecia in women of color. Int J Womens Dermatol. 2019 Aug 22;5(5):314-319. doi: 10.1016/j.ijwd.2019.08.005. eCollection 2019 Dec.
PubMed 31909150Jimenez F, Izeta A, Poblet E. Morphometric analysis of the human scalp hair follicle: practical implications for the hair transplant surgeon and hair regeneration studies. Dermatol Surg. 2011 Jan;37(1):58-64. doi: 10.1111/j.1524-4725.2010.01809.x. Epub 2010 Nov 11.
PubMed 21070465Savoia A, Accardo C, Vannini F, Di Pasquale B, Baldi A. Outcomes in thread lift for facial rejuvenation: a study performed with happy lift revitalizing. Dermatol Ther (Heidelb). 2014 Jun;4(1):103-14. doi: 10.1007/s13555-014-0041-6. Epub 2014 Jan 17.
PubMed 24436079Shimojima K, Hashimoto M, Yamaoka Y, Kapoor KM. Combination Treatment with Cryolipolysis and Hyaluronic Acid Fillers for Jawline Enhancement. Clin Cosmet Investig Dermatol. 2024 Dec 20;17:2989-2998. doi: 10.2147/CCID.S492091. eCollection 2024.
PubMed 39723342Tsur Shenhav L, Shehade W, Muravnik G, Horovitz T, Artzi O. The Safety and Efficacy of a Dual CO 2 and 1570-nm Hybrid Laser for Periorbital Rejuvenation. Dermatol Surg. 2023 May 1;49(5):479-482. doi: 10.1097/DSS.0000000000003750. Epub 2023 Mar 6.
PubMed 36877122Constantinou A, Polak-Witka K, Tomazou M, Oulas A, Kanti V, Schwarzer R, Helmuth J, Edelmann A, Blume-Peytavi U, Spyrou GM, Vogt A. Dysbiosis and Enhanced Beta-Defensin Production in Hair Follicles of Patients with Lichen Planopilaris and Frontal Fibrosing Alopecia. Biomedicines. 2021 Mar 7;9(3):266. doi: 10.3390/biomedicines9030266.
PubMed 33800045Sanchez P, Serrano Falcon C, Martinez Rodriguez S, Torres JM, Serrano S, Ortega E. mRNA Levels of Aromatase, 5alpha-Reductase Isozymes, and Prostate Cancer-Related Genes in Plucked Hair from Young Men with Androgenic Alopecia. Int J Mol Sci. 2023 Dec 14;24(24):17461. doi: 10.3390/ijms242417461.
PubMed 38139289
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1470 nm Non-Ablative Laser for the Treatment of Scarring Alopecia: A Clinical and Mechanistic Study
- ClinicalTrials.gov ID
- NCT06946550
- Acronym / sponsor ID
- 2025-16805
- Conditions
- Scarring Alopecia
- Keywords
- alopecia, laser
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Sciton, American Society for Laser Surgery and Medicine
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does a non-ablative laser work to effectively treat scarring alopecia?
- 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scarring alopecia | Experimental | Device: 1470nm non-ablative fractional laserPatients with scarring alopecia will receive 3 treatments with the non-ablative Sciton HALO laser (1470nm). Each laser treatment will take approximately 10 to 15 minutes per subject. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1470nm non-ablative fractional laserPatients with scarring alopecia will be treated with the non-ablative Sciton HALO laser (1470nm). | Device | Scarring alopecia |
Primary outcome
Clinician Global Aesthetic Improvement Scale
Time frame: Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15
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.
Subject Global Aesthetic Improvement Scale
Time frame: Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15
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.
Hair density
Time frame: Baseline/Month 1, 2, 3, 4, 6, 9, 12, 15
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).
Hair counts
Time frame: Baseline/Month 1, 2, 3, 4, 6, 9, 12, 15
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).
2 secondary outcomes
Subject Satisfaction Questionnaire
Time frame: Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15
Change in Dermatology Life Quality Index
Time frame: From Baseline/Month 1 to Month 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 19052558Karnik P, Tekeste Z, McCormick TS, Gilliam AC, Price VH, Cooper KD, Mirmirani P. Hair follicle stem cell-specific PPARgamma deletion causes scarring alopecia. J Invest Dermatol. 2009 May;129(5):1243-57. doi: 10.1038/jid.2008.369. Epub 2008 Dec 4.
- Background: PubMed 31050755Anzai A, Wang EHC, Lee EY, Aoki V, Christiano AM. Pathomechanisms of immune-mediated alopecia. Int Immunol. 2019 Jul 13;31(7):439-447. doi: 10.1093/intimm/dxz039.
- Background: PubMed 34053592Hordinsky M. Scarring Alopecia: Diagnosis and New Treatment Options. Dermatol Clin. 2021 Jul;39(3):383-388. doi: 10.1016/j.det.2021.05.001.
- Background: PubMed 12756226Van Mater D, Kolligs FT, Dlugosz AA, Fearon ER. Transient activation of beta -catenin signaling in cutaneous keratinocytes is sufficient to trigger the active growth phase of the hair cycle in mice. Genes Dev. 2003 May 15;17(10):1219-24. doi: 10.1101/gad.1076103.
- Background: PubMed 35007355Jamerson TA, Conover Talbot C Jr, Dina Y, Kwatra SG, Garza LA, Aguh C. Gene expression profiling suggests severe, extensive central centrifugal cicatricial alopecia may be both clinically and biologically distinct from limited disease subtypes. Exp Dermatol. 2022 May;31(5):789-793. doi: 10.1111/exd.14524. Epub 2022 Jan 20.
- Background: PubMed 32633447Tanakol A, Oba MC, Uzuncakmak TK, Askin O, Kutlubay Z. Treatment of alopecia areata with 2940-nm fractional erbium:yttrium-aluminum-garnet laser. Dermatol Ther. 2020 Nov;33(6):e13978. doi: 10.1111/dth.13978. Epub 2020 Aug 6.
- Background: PubMed 29340854Cho SB, Goo BL, Zheng Z, Yoo KH, Kang JS, Kim H. Therapeutic efficacy and safety of a 1927-nm fractionated thulium laser on pattern hair loss: an evaluator-blinded, split-scalp study. Lasers Med Sci. 2018 May;33(4):851-859. doi: 10.1007/s10103-018-2437-5. Epub 2018 Jan 16.
- Background: PubMed 26885014Ke J, Guan H, Li S, Xu L, Zhang L, Yan Y. Erbium: YAG laser (2,940 nm) treatment stimulates hair growth through upregulating Wnt 10b and beta-catenin expression in C57BL/6 mice. Int J Clin Exp Med. 2015 Nov 15;8(11):20883-9. eCollection 2015.
- Background: PubMed 31909150Raffi J, Suresh R, Agbai O. Clinical recognition and management of alopecia in women of color. Int J Womens Dermatol. 2019 Aug 22;5(5):314-319. doi: 10.1016/j.ijwd.2019.08.005. eCollection 2019 Dec.
- Background: PubMed 21070465Jimenez F, Izeta A, Poblet E. Morphometric analysis of the human scalp hair follicle: practical implications for the hair transplant surgeon and hair regeneration studies. Dermatol Surg. 2011 Jan;37(1):58-64. doi: 10.1111/j.1524-4725.2010.01809.x. Epub 2010 Nov 11.
- Background: PubMed 24436079Savoia A, Accardo C, Vannini F, Di Pasquale B, Baldi A. Outcomes in thread lift for facial rejuvenation: a study performed with happy lift revitalizing. Dermatol Ther (Heidelb). 2014 Jun;4(1):103-14. doi: 10.1007/s13555-014-0041-6. Epub 2014 Jan 17.
- Background: PubMed 39723342Shimojima K, Hashimoto M, Yamaoka Y, Kapoor KM. Combination Treatment with Cryolipolysis and Hyaluronic Acid Fillers for Jawline Enhancement. Clin Cosmet Investig Dermatol. 2024 Dec 20;17:2989-2998. doi: 10.2147/CCID.S492091. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kseniya Kobets, MD principal investigator
Albert Einstein College of Medicine Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1470nm non-ablative fractional laser in people with Scarring Alopecia, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anika Jallorina, BS (618-704-8716, ajallorina@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Global Aesthetic Improvement Scale (time frame: Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06946550, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.