Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia

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Brief Title

Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia

Official Title

A Pilot Study Evaluating the Safety and Efficacy of a Fractionated Thulium Laser and KeraFactor for the Treatment of Alopecia

Brief Summary

      The objective of this clinical study is to assess the safety and efficacy of using a laser
      and hair growth factors in the treatment of male-pattern hair loss. Participating subjects
      will receive up to two (2) treatments per month for 6 months with the laser and
      post-treatment topically applied hair growth factors and will have a 6 month follow-up
      period.
    

Detailed Description

      This is a single-center, open-label, baseline-controlled, study evaluating the use of a
      Thulium laser (1927nm) and post-treatment topically applied KeraFactor, which contain
      hair-stimulating growth factors, in the treatment of androgenetic alopecia. The study may
      enroll up to 20 subjects looking for improvement in their hair loss. Multiple treatment areas
      per subject may be included. Each subject will receive up to two (2) treatments per month
      over a 3-month period. Follow Up Visits are planned for 3, and 9 months post last treatment.
      Standardized photography of the treatment 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.

      The follow up phase will consist of before and after photographs graded by blinded observers.
      Subjects are instructed to inform clinical staff after the treatment if they experience any
      adverse events.
    


Study Type

Interventional


Primary Outcome

Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at week 12 of treatment.

Secondary Outcome

 Percentage of subjects with score of 2 or 3 on Patient Satisfaction Questionnaire at week 12 of treatment.

Condition

Androgenetic Alopecia

Intervention

Fractionated Thulium laser

Study Arms / Comparison Groups

 Fractionated Thulium Laser and KeraFactor
Description:  All participating subjects will serve as their own baseline control and will receive treatment of their androgenetic alopecia with LaseMD, a 1927nm Fractionated Thulium laser and post-treatment topically applied KeraFactor every 2 weeks for 12 week period.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

June 1, 2021

Completion Date

December 31, 2024

Primary Completion Date

June 30, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Subject must voluntarily sign and date an IRB approved informed consent form

          -  Subjects with diagnosis of androgenetic alopecia with hair loss recorded over the past
             6 months. (Ludwig Savin Scale: Class I-4, II-1, II-2 for females and Norwood Hamilton
             Class 3-4 for males

          -  Able to read, understand and voluntarily provide written informed consent.

          -  Healthy male or female, ≥ 18 years of age at time of informed consent up to 65 years
             of age, seeking treatment for hair loss.

          -  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.

          -  Women of child-bearing age are required to be using a reliable, non-hormonal method of
             birth control for the duration of the study. Subjects will be asked to have a negative
             Urine Pregnancy test at baseline.

        Exclusion Criteria:

          -  Subjects does not have the capacity to consent to the study

          -  Subject has other types of alopecia of the scalp (i.g., alopecia areata, scarring
             alopecia)

          -  Use of minoxidil or 5-alpha reductase inhibitors (i.e., finasteride, dutasteride) 3
             months prior to screening date.

          -  Any medical condition that in the consideration of the investigator, would present an
             increased risk of a photosensitivity reaction to the subject.

          -  Pregnant in the last 12 months, intending to become pregnant, postpartum or nursing in
             the last 12 months.

          -  Any previous surgical procedure in the treatment area in the past 12 months, or major
             surgery in the last 6 months.

          -  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: Immunosuppressive
             medications/biologics, 6 months prior to and during the study. Accutane or other
             systemic retinoids within the past twelve months.

          -  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 as well as Polycystic
             Ovarian Syndrome (PCOS) in females.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Kseniya Kobets, MD, 718-920-8352, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04882969

Organization ID

2021-12914


Responsible Party

Principal Investigator

Study Sponsor

Montefiore Medical Center


Study Sponsor

Kseniya Kobets, MD, Principal Investigator, Montefiore Medical Center


Verification Date

May 2021