Clinical trial NCT05460611: 1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia
Official title: A Pilot Study Evaluating the Safety and Efficacy of a 1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scarring Alopecia
Androgenetic Alopecia
Keywords: alopecia
laser
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Sciton
First posted: 2022-07-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Live and Photographic assessment of hair loss
timeFrame: month 1
measure: Hair density
timeFrame: month 1
measure: Hair counts
timeFrame: month 1
measure: Live and Photographic assessment of hair loss
timeFrame: Month 2
measure: Live and Photographic assessment of hair loss
timeFrame: Month 3
measure: Live and Photographic assessment of hair loss
timeFrame: Month 6
measure: Live and Photographic assessment of hair loss
timeFrame: Month 9
measure: Live and Photographic assessment of hair loss
timeFrame: Month 12
measure: Live and Photographic assessment of hair loss
timeFrame: Month 15
measure: Hair density
timeFrame: Month 6
measure: Hair density
timeFrame: Month 9
measure: Hair density
timeFrame: Month 12
measure: Hair density
timeFrame: Month 15
measure: Hair counts
timeFrame: month 6
measure: Hair counts
timeFrame: month 9
measure: Hair counts
timeFrame: month 12
measure: Hair counts
timeFrame: month 15
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: months 1
measure: Subject Satisfaction
timeFrame: month 2
measure: Subject Satisfaction
timeFrame: month 3
measure: Subject Satisfaction
timeFrame: month 6
measure: Subject Satisfaction
timeFrame: month 9
measure: Subject Satisfation
timeFrame: month 12
measure: Subject Satisfaction
timeFrame: month 15
Other outcomes:
Locations:
city: Elmsford
country: United States
facility: Montefiore Einstein Advanced Care
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine Montefiore Medical Center
name: Kseniya Kobets, MD
role: PRINCIPAL_INVESTIGATOR
References: