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

NCT05460611 | Recruiting DMC FDA Device

• 1 other identifier: 2022-14192
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Scarring Alopecia; Androgenetic Alopecia

Keywords

alopecia; laser

Outcome Measures

Primary Outcomes (3)

• Live and Photographic assessment of hair loss

  Live and Photographic assessment of hair loss will be assessed using the 7-point Clinician rated Global Aesthetic Improvement Scale (CGAIS). The GAIS is a standardized tool used in dermatology and aesthetic medicine to evaluate treatment success for hair loss (such as androgenetic and scarring alopecia). The 7-point GAIS is scored using a scale ranging from -3 (Greatly decreased - hair growth and density) to 3 (Greatly increased - hair growth and density). A score of zero represents no change.

  Month 1 (baseline), Month 2, Month 3, Month 6, Month 9, Month 12, Month 15

• Hair Density

  Hair density will be assessed using the Canfield HairMetrix imaging device. The average number of hairs per follicular unit will be summarized by arm using descriptive statistics.

  Month 1 (baseline), and during the four follow-up periods at Month 6, Month 9, Month 12, and Month 15 (i.e., up to 14 months after initial treatment)

• Hair Counts

  Hair counts will also be assessed using the Canfield HairMetrix imaging device. Hair counts/cm\^2 will be summarized by study arm using descriptive statistics.

  Month 1 (baseline), and during the four follow-up periods at Month 6, Month 9, Month 12, and Month 15 (i.e., up to 14 months after initial treatment)

Secondary Outcomes (5)

• Subject Satisfaction - Overall

  Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15

• Subject Satisfaction - Hair Thickness

  Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15

• Subject Satisfaction - Hair Shedding/Loss

  Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15

• Subject Satisfaction - Hair Darkness

  Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15

• Subject Satisfaction - Satisfaction with Treatment

  Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15

Study Arms (2)

Androgenetic Alopecia

EXPERIMENTAL

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

Scarring Alopecia

EXPERIMENTAL

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

Interventions

Sciton HALO 1470nm Non-ablative laser DEVICE

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

Androgenetic Alopecia; Scarring Alopecia

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject does not have the capacity to consent to the study
• Subject has other types of alopecia of the scalp like alopecia areata
• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Sciton: collaborator

Study Sites (1)

Montefiore Einstein Advanced Care

Elmsford, New York, 10523, United States

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kseniya Kobets, MD

  Albert Einstein College of Medicine Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anika Jallorina, BS

CONTACT

618-704-8716; ajallorina@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 15, 2022
• Study Start: December 7, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)