RECRUITING

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

Conditions

Scarring Alopecia Androgenetic Alopecia alopecia laser

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Pilot Study Evaluating the Safety and Efficacy of a 1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia

Quick Facts

Study Start:2023-12-07

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05460611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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 regime 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.	* 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 * 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: * Smoking or vaping in the past 12 months. * History of 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.

Inclusion Criteria

Exclusion 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
* 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 regime 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.

* 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
* 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:
* Smoking or vaping in the past 12 months.
* History of 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.

Contacts and Locations

Study Contact

Janet Choi, BS

CONTACT

(917)680-9907

janet.choi@einsteinmed.edu

Principal Investigator

Kseniya Kobets, MD

PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine Montefiore Medical Center

Study Locations (Sites)

Montefiore Einstein Advanced Care

Elmsford, New York, 10523

United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

Kseniya Kobets, MD, PRINCIPAL_INVESTIGATOR, Albert Einstein College of Medicine Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-07

Study Completion Date2025-12

Study Record Updates

Study Start Date2023-12-07

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

alopecia
laser

Additional Relevant MeSH Terms

Scarring Alopecia
Androgenetic Alopecia