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

NCT ID: NCT05460611

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-07
• Study Completion Date: 2026-07-31

Brief Summary

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.

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. Post-treatment care will follow standard of care, including the application of topical betamethasone dipropionate cream 0.05% to the treated area. 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, however, it has not been tested for the treatment of androgenetic alopecia or scarring alopecia, thus this is a novel study to investigate its effectiveness

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.

Conditions

Scarring Alopecia; Androgenetic Alopecia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sciton HALO 1470nm Non-ablative laser

Intervention Type: DEVICE

Patients will be treated with the 1470nm non-ablative laser.

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.

Group Type: EXPERIMENTAL

Sciton HALO 1470nm Non-ablative laser

Intervention Type: DEVICE

Patients will be treated with the 1470nm non-ablative laser.

Interventions

Sciton HALO 1470nm Non-ablative laser

Patients will be treated with the 1470nm non-ablative laser.

Intervention Type: DEVICE

Eligibility Criteria

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
• Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 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 regimen 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
• 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 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 uncontrolled 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sciton

INDUSTRY

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kseniya Kobets, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine Montefiore Medical Center

Locations

Montefiore Einstein Advanced Care

Elmsford, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anika Jallorina, BS

Role: CONTACT

ajallorina@montefiore.org

618-704-8716

Facility Contacts

Gabriela Gjini

Role: primary

ggjini@montefiore.org

914-457-4130

Other Identifiers

2022-14192

Identifier Type: -

Identifier Source: org_study_id