Non-Ablative Laser to Treat Scarring Alopecia With Hair Follicle Gene Expression Analysis

Official title

1470 nm Non-Ablative Laser for the Treatment of Scarring Alopecia: A Clinical and Mechanistic Study

Overview

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

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.

Interventions

• Device 1470nm non-ablative fractional laser
  Patients with scarring alopecia will be treated with the non-ablative Sciton HALO laser (1470nm).

Primary outcome measures

• Clinician Global Aesthetic Improvement Scale [Time frame: Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15]
• Subject Global Aesthetic Improvement Scale [Time frame: Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15]
• Hair density [Time frame: Baseline/Month 1, 2, 3, 4, 6, 9, 12, 15]
• Hair counts [Time frame: Baseline/Month 1, 2, 3, 4, 6, 9, 12, 15]

Secondary outcome measures (2)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Montefiore Einstein Advanced Care — Elmsford

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. PMID 19052558
• Anzai 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. PMID 31050755
• Hordinsky M. Scarring Alopecia: Diagnosis and New Treatment Options. Dermatol Clin. 2021 Jul;39(3):383-388. doi: 10.1016/j.det.2021.05.001. PMID 34053592
• Van 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. PMID 12756226
• Jamerson 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. PMID 35007355
• Tanakol 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. PMID 32633447
• Cho 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. PMID 29340854
• Ke 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. PMID 26885014

Identifiers

NCT: NCT06946550 · 2025-16805

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗