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

Phase

N/A

Condition

Male Pattern Baldness

Hair Loss

Alopecia

Treatment

Sciton HALO 1470nm Non-ablative laser

Clinical Study ID

NCT05460611

2022-14192

Ages 18-99
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Healthy males and females, ≥ 18 years of age at time of informed consent, seekingtreatment 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 alopeciawith hair loss recorded over the past 6 months
Subjects must have a stable hair loss treatment regimen with a plateau in resultsfor 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 changesto their daily hair treatment regimen during the study
Subjects able and willing to comply with the treatment protocol and follow-upschedule and requirements
Understands and accepts the obligation not to undergo any other procedures in theareas to be treated through the follow-up period

Exclusion

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) 3months 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 presentan increased risk of a photosensitivity reaction to the subject
Any previous surgical procedure in the treatment area in the past 12 months, ormajor surgery in the last 6 months
Allergy or history of prior reaction to lidocaine
History of immunosuppression/immune deficiency disorders (including AIDS and HIVinfection), 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 studyii. 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 bleedingdisorders
History of major depressive disorders or endocrine disorders including but notlimited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism

Study Design

Sciton HALO 1470nm Non-ablative laser

December 07, 2023

July 31, 2026

Study 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.

Connect with a study center

Montefiore Einstein Advanced Care
Elmsford, New York 10523
United States
Active - Recruiting

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