1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia

A Pilot Study Evaluating the Safety and Efficacy of a 1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia

Single-center, open-label, baseline-controlled, pilot study evaluating the use of a Nonablative 1470 nm laser for the treatment of androgenetic alopecia and scarring alopecia.

Study Overview

• Status: Recruiting
• Conditions: Androgenetic Alopecia; Scarring Alopecia
• Intervention / Treatment: Device: Sciton HALO 1470nm Non-ablative laser

Detailed Description

Single-center, open-label, baseline-controlled, pilot study evaluating the use of a Nonablative 1470 nm laser for the treatment of androgenetic alopecia and scarring alopecia. The study may enroll up to 10 participants looking for improvement in their hair loss. All participants will have biopsy-proven alopecia before enrollment. There will be two treatment arms with 5 participants in the androgenetic alopecia arm and 5 participants in the scarring alopecia arm. Multiple treatment areas of the scalp may be performed. Each subject will receive up to three treatments. Follow-up visits are planned for months 6, 9, 12, and 15. Standardized photography, hair density measurement of the treated scalp areas will be recorded Pre and Post Treatment at each visit. Measurement outcomes will be compared to baseline. During the initial visit, subjects who meet the study's eligibility criteria will receive the first treatment after signing informed consent form.

For this study, the investigators will use non-ablative HALO laser (1470nm) (Sciton). 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. Each laser treatment will take approximately 10 to 15 minutes per subject. Pretreatment procedure will consist of topical anesthetic then cleaning of the affected area of the scalp with antiseptic, either 70% ethanol or 3% hydrogen peroxide. The U.S. Food and Drug Administration (FDA) has approved the 1470 nm laser for dermatologic purposes.

The follow up phase will consist of clinical assessments including before and after photographs graded by blinded observers and hair density evaluation using Canfield HairMetrix ® device. Subjects are instructed to inform clinical staff after the treatment if they experience any adverse events and will complete patient questionnaires, pain score, and self-assessment of hair growth.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janet Choi, BS; Phone Number: (917)680-9907; Email: janet.choi@einsteinmed.edu

Study Locations

• United States
  • New York
    • Elmsford, New York, United States, 10523
      • Recruiting
      • Montefiore Einstein Advanced Care
      • Contact: Hailey Konisky, BS; Phone Number: 518-596-4306; Email: hailey.konisky@einsteinmed.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy males and females, ≥ 18 years of age at time of informed consent, seeking treatment for hair loss.
• Subject must voluntarily sign and date an IRB approved informed consent form
• Subjects with diagnosis of biopsy proven androgenetic alopecia or scarring alopecia with hair loss recorded over the past 6 months
• Able to read, understand and voluntarily provide written informed consent.
• Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regime 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 through the follow-up period.

Exclusion Criteria:

• Subject does not have the capacity to consent to the study
• Subject has other types of alopecia of the scalp like alopecia areata
• Use of minoxidil or 5-alpha reductase inhibitors (i.e., finasteride, dutasteride) 3 months prior to screening date.
• History of intralesional steroid injections to the scalp in the last 12 months
• Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject.
• Any previous 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 for prior 12 months.

• History or current use of the following prescription medications:

  i. Immunosuppressive medications/biologics, 6 months prior to and during the study ii. Accutane or other systemic retinoids within the past twelve months

• Smoking or vaping in the past 12 months.
• History of hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders.
• History of major depressive disorders or endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Androgenetic Alopecia; 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.	Device: Sciton HALO 1470nm Non-ablative laser; Patients will be treated with the 1470nm non-ablative laser.
Experimental: Scarring Alopecia; 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.	Device: Sciton HALO 1470nm Non-ablative laser; Patients will be treated with the 1470nm non-ablative laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live and Photographic assessment of hair loss	GAIS (Global Aesthetic Improvement Scale)- Scored from -3 greatly decreased in hair growth and density to 3 greatly increased in hair growth and density. A score of zero represents no change. This is the baseline assessment.	month 1
Hair density	using Canfield HairMetrix imaging device; average number of hairs per follicular unit as baseline assessment	month 1
Hair counts	using Canfield HairMetrix imaging device; hair count per cm squared as baseline assessment	month 1
Live and Photographic assessment of hair loss	GAIS (Global Aesthetic Improvement Scale)- Scored from -3 greatly decreased in hair growth and density to 3 greatly increased in hair growth and density. A score of zero represents no change.	Month 2
Live and Photographic assessment of hair loss	GAIS (Global Aesthetic Improvement Scale)- Scored from -3 greatly decreased in hair growth and density to 3 greatly increased in hair growth and density. A score of zero represents no change.	Month 3
Live and Photographic assessment of hair loss	GAIS (Global Aesthetic Improvement Scale)- Scored from -3 greatly decreased in hair growth and density to 3 greatly increased in hair growth and density. A score of zero represents no change.	Month 6
Live and Photographic assessment of hair loss	GAIS (Global Aesthetic Improvement Scale)- Scored from -3 greatly decreased in hair growth and density to 3 greatly increased in hair growth and density. A score of zero represents no change.	Month 9
Live and Photographic assessment of hair loss	GAIS (Global Aesthetic Improvement Scale)- Scored from -3 greatly decreased in hair growth and density to 3 greatly increased in hair growth and density. A score of zero represents no change.	Month 12
Live and Photographic assessment of hair loss	GAIS (Global Aesthetic Improvement Scale)- Scored from -3 greatly decreased in hair growth and density to 3 greatly increased in hair growth and density. A score of zero represents no change.	Month 15
Hair density	using Canfield HairMetrix imaging device; average number of hairs per follicular unit	Month 6
Hair density	using Canfield HairMetrix imaging device; average number of hairs per follicular unit	Month 9
Hair density	using Canfield HairMetrix imaging device; average number of hairs per follicular unit	Month 12
Hair density	using Canfield HairMetrix imaging device; average number of hairs per follicular unit	Month 15
Hair counts	using Canfield HairMetrix imaging device; hair count per cm squared	month 6
Hair counts	using Canfield HairMetrix imaging device; hair count per cm squared	month 9
Hair counts	using Canfield HairMetrix imaging device; hair count per cm squared	month 12
Hair counts	using Canfield HairMetrix imaging device; hair count per cm squared	month 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Satisfaction	Please choose the option that better represents the change in how your hair looks OVERALL in the area treated?; Please choose the option that better represents the change in your hair THICKNESS in the area treated?; Please choose the option that better represents the change in your hair SHEDDING/LOSS in the area treated?; Please choose the option that better represents the change in your hair DARKNESS in the area treated.; Please choose the option that better represents the change in your hair DARKNESS in the area treated.-3 = Greatly decreased-2 = Moderately decreased-1 = Slightly decreased0 = No change1 = Slightly increased2 = Moderately increased3 = Greatly increased	months 1
Subject Satisfaction	Please choose the option that better represents the change in how your hair looks OVERALL in the area treated?; Please choose the option that better represents the change in your hair THICKNESS in the area treated?; Please choose the option that better represents the change in your hair SHEDDING/LOSS in the area treated?; Please choose the option that better represents the change in your hair DARKNESS in the area treated.; Please choose the option that better represents the change in your hair DARKNESS in the area treated.-3 = Greatly decreased-2 = Moderately decreased-1 = Slightly decreased0 = No change1 = Slightly increased2 = Moderately increased3 = Greatly increased	month 2
Subject Satisfaction	Please choose the option that better represents the change in how your hair looks OVERALL in the area treated?; Please choose the option that better represents the change in your hair THICKNESS in the area treated?; Please choose the option that better represents the change in your hair SHEDDING/LOSS in the area treated?; Please choose the option that better represents the change in your hair DARKNESS in the area treated.; Please choose the option that better represents the change in your hair DARKNESS in the area treated.-3 = Greatly decreased-2 = Moderately decreased-1 = Slightly decreased0 = No change1 = Slightly increased2 = Moderately increased3 = Greatly increased	month 3
Subject Satisfaction	Please choose the option that better represents the change in how your hair looks OVERALL in the area treated?; Please choose the option that better represents the change in your hair THICKNESS in the area treated?; Please choose the option that better represents the change in your hair SHEDDING/LOSS in the area treated?; Please choose the option that better represents the change in your hair DARKNESS in the area treated.; Please choose the option that better represents the change in your hair DARKNESS in the area treated.-3 = Greatly decreased-2 = Moderately decreased-1 = Slightly decreased0 = No change1 = Slightly increased2 = Moderately increased3 = Greatly increased	month 6
Subject Satisfaction	Please choose the option that better represents the change in how your hair looks OVERALL in the area treated?; Please choose the option that better represents the change in your hair THICKNESS in the area treated?; Please choose the option that better represents the change in your hair SHEDDING/LOSS in the area treated?; Please choose the option that better represents the change in your hair DARKNESS in the area treated.; Please choose the option that better represents the change in your hair DARKNESS in the area treated.-3 = Greatly decreased-2 = Moderately decreased-1 = Slightly decreased0 = No change1 = Slightly increased2 = Moderately increased3 = Greatly increased	month 9
Subject Satisfation	Please choose the option that better represents the change in how your hair looks OVERALL in the area treated?; Please choose the option that better represents the change in your hair THICKNESS in the area treated?; Please choose the option that better represents the change in your hair SHEDDING/LOSS in the area treated?; Please choose the option that better represents the change in your hair DARKNESS in the area treated.; Please choose the option that better represents the change in your hair DARKNESS in the area treated.-3 = Greatly decreased-2 = Moderately decreased-1 = Slightly decreased0 = No change1 = Slightly increased2 = Moderately increased3 = Greatly increased	month 12
Subject Satisfaction	Please choose the option that better represents the change in how your hair looks OVERALL in the area treated?; Please choose the option that better represents the change in your hair THICKNESS in the area treated?; Please choose the option that better represents the change in your hair SHEDDING/LOSS in the area treated?; Please choose the option that better represents the change in your hair DARKNESS in the area treated.; Please choose the option that better represents the change in your hair DARKNESS in the area treated.-3 = Greatly decreased-2 = Moderately decreased-1 = Slightly decreased0 = No change1 = Slightly increased2 = Moderately increased3 = Greatly increased	month 15

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Sciton
• Investigators: Principal Investigator: Kseniya Kobets, MD, Albert Einstein College of Medicine Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: laser; alopecia
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Pathological Conditions, Anatomical; Fibrosis; Hypotrichosis; Hair Diseases; Cicatrix; Alopecia; Alopecia Areata
• Other Study ID Numbers: 2022-14192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No