Recruiting

Nonablative Laser

Sponsor:

Montefiore Medical Center

Code:

NCT05460611

Conditions

Scarring Alopecia

Androgenetic Alopecia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Sciton HALO 1470nm Non-ablative laser

Study Details

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

Study ID

NCT05460611

Start date

Dec 7, 2023

Status verified date

Jun, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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
  • 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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Sciton HALO 1470nm Non-ablative laser

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

Primary outcome measure

  • Live and Photographic assessment of hair loss [ Time Frame: Month 1 (baseline), Month 2, Month 3, Month 6, Month 9, Month 12, Month 15 ]
  • Hair Density [ Time Frame: 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 [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Anika Jallorina, BS

618-704-8716ajallorina@montefiore.org

Locations

Montefiore Einstein Advanced Care

Recruiting

Elmsford, New York, United States, 10523

Contacts

Gabriela Gjini

914-457-4130ggjini@montefiore.org

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • alopecia
  • laser

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-06-11.