Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia

NCT04882969 | Withdrawn DMC FDA Device

• 1 other identifier: 2021-12914
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia

Keywords

alopecia; androgenetic; laser; hair loss

Outcome Measures

Primary Outcomes (2)

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

  Clinician Global Aesthetic Improvement Scale (CGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth. 1. Greatly decreased (-3) 2. Moderately decreased (-2) 3. Slightly decreased (-1) 4. No change (0) 5. Slightly increased (+1) 6. Moderately increased (+2) 7. Greatly increased (+3) Based on a live assessment of the subject while referring to the subject's pre-treatment scalp photographs, the clinician will make an assessment of post-treatment hair growth.

  12 weeks

• Percentage of subjects with score of 2 or 3 on Subject Global Aesthetic Improvement at week 12 of treatment.

  Subject Global Aesthetic Improvement Scale (SGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth. 1. Greatly decreased (-3) 2. Moderately decreased (-2) 3. Slightly decreased (-1) 4. No change (0) 5. Slightly increased (+1) 6. Moderately increased (+2) 7. Greatly increased (+3) Subjects will be given a hand mirror for self-assessment of post-treatment hair growth compared to subject's pre-treatment scalp photographs.

  12 weeks

Secondary Outcomes (2)

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

  12 weeks

• Reported pain score on Numeric Rating Scale for Pain

  12 weeks

Study Arms (1)

Fractionated Thulium Laser and KeraFactor

EXPERIMENTAL

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.

Device: Fractionated Thulium laser

Interventions

Fractionated Thulium laser DEVICE

LaseMD Lutronic Laser is a 1927-nm fractionated thulium laser, which is better absorbed by water than non-ablative 1,540-nm erbium glass laser energy. The laser energy and power can be customized to target a specific penetration depth and achieve selective photothermolysis in skin while mitigating injury to surrounding tissue. The thermal energy generated by the laser has been shown to facilitate the delivery of kerafactor, which contain hair growth factors to stimulate follicular progenitor cell proliferation and differentiation into follicular keratinocytes to promote hair growth.

Also known as: LaseMD Lutronic Laser

Fractionated Thulium Laser and KeraFactor

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kseniya Kobets, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Medicine (Dermatology)

Model Details: Each participating subject will serve as his or her baseline control and will receive up to two (2) treatments per month for 3 months with Thulium laser and post-laser treatment topically applied Kerafactor.

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: September 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2024
• Last Updated: August 12, 2021

Record last verified: 2021-08

Locations

US (1)