Thulium Laser and Topical Platelet Rich Plasma (PRP) vs. PRP Injection for the Treatment of Male Androgenetic Alopecia

NCT ID: NCT05129254

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2025-12-31

Brief Summary

The objective of this clinical study is to compare the safety and efficacy of a laser and topically applied platelet-rich plasma vs. platelet rich plasma injection in the treatment of male-pattern hair loss. Participating subjects will receive up to four (4) monthly treatments and will have a 12 month follow-up period.

Detailed Description

This is a single institution, open-label, baseline-controlled, prospective study evaluating the use of a non-ablative fractionated thulium laser and topical autologous platelet-rich plasma (PRP) vs. PRP injection for the treatment of male androgenetic alopecia (MAA). Given that this is a feasibility study, the investigators do provide formal sample size calculations. The findings of the study will inform that effect size associated with the treatment under study, which will inform the sample size (and power) calculations of a full, large-scale study. For this feasibility study, the investigators conservatively estimated the number of eligible patients that can reasonably enroll in the study time frame. Over the course of 1 year, the investigators typically see 50 patients with this condition annually. Of those, the investigators anticipate 25-50% would be eligible and agree to participate in the study. Given this, the investigators reasonably believe the enrollment will be 12 male subjects, ≥ 18 years of age at time of signed informed consent, of whom 6 will be randomized to receive laser + topical PRP and 6 to receive PRP injection. Follow-up visits are planned for months 7, 10, 13, and 16. 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.

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thulium laser (1927nm) and post-treatment topically administered platelet rich plasma (PRP)

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 autologous platelet rich plasma at monthly intervals for a total of 4 treatment. The total duration of laser application, venipuncture, PRP preparation, and topical administration will take approximately 30 minutes. Post-treatment surveillance: The subject will be observed in the clinic under direct supervision of the treating physician for any post-treatment side-effects for up to 15 minutes.

Group Type: EXPERIMENTAL

Fractionated Thulium laser

Intervention Type: DEVICE

For this study, the investigators will use non-ablative fractional Thulium laser (1927 nm), provided by LaseMD, (Lutronic, Inc, USA). 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 parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by LaseMD. More than one affected area of the scalp may be treated per session. Each laser treatment will take approximately 10 to 15 minutes per subject. Pretreatment preparation will consist of cleaning the affected area of the scalp with antiseptic, either 70% ethanol or 3% hydrogen peroxide.

Autologous Platelet Rich Plasma Topical Application

Intervention Type: PROCEDURE

Platelet rich plasma (PRP) will be collected from participant in accordance with FDA section 21CFR640.34 regulation on collection and preparation of PRP. The collected blood will be processed according to manufacturer protocol to obtain PRP, which will be applied topically with a syringe to one or more affected areas on the participant's scalp that were previously treated with thulium laser.

Platelet rich plasma injection

All participating subjects will serve as their own baseline control and will receive treatment of their androgenetic alopecia with autologous platelet rich plasma injection at monthly intervals for a total of 4 treatment. The total duration of venipuncture, PRP preparation, and injection will take approximately 15 minutes. Post-treatment surveillance: The subject will be observed in the clinic under direct supervision of the treating physician for any post-treatment side-effects for up to 15 minutes.

Group Type: EXPERIMENTAL

Autologous Platelet Rich Plasma Injection

Intervention Type: PROCEDURE

Platelet rich plasma (PRP) will be collected from participant in accordance with FDA section 21CFR640.34 regulation on collection and preparation of PRP. The collected blood will be processed according to manufacturer protocol to obtain PRP, which will be injected with a syringe and needle subcutaneously into the participant's scalp.

Interventions

Fractionated Thulium laser

For this study, the investigators will use non-ablative fractional Thulium laser (1927 nm), provided by LaseMD, (Lutronic, Inc, USA). 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 parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by LaseMD. More than one affected area of the scalp may be treated per session. Each laser treatment will take approximately 10 to 15 minutes per subject. Pretreatment preparation will consist of cleaning the affected area of the scalp with antiseptic, either 70% ethanol or 3% hydrogen peroxide.

Intervention Type: DEVICE

Autologous Platelet Rich Plasma Injection

Platelet rich plasma (PRP) will be collected from participant in accordance with FDA section 21CFR640.34 regulation on collection and preparation of PRP. The collected blood will be processed according to manufacturer protocol to obtain PRP, which will be injected with a syringe and needle subcutaneously into the participant's scalp.

Intervention Type: PROCEDURE

Autologous Platelet Rich Plasma Topical Application

Platelet rich plasma (PRP) will be collected from participant in accordance with FDA section 21CFR640.34 regulation on collection and preparation of PRP. The collected blood will be processed according to manufacturer protocol to obtain PRP, which will be applied topically with a syringe to one or more affected areas on the participant's scalp that were previously treated with thulium laser.

Intervention Type: PROCEDURE

Other Intervention Names

LaseMD Lutronic Laser

Eligibility Criteria

Inclusion Criteria

• Healthy male, ≥ 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 androgenetic alopecia with hair loss recorded over the past 6 months. (Norwood Hamilton Class 3-4 for males)
• 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.

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.
• 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:

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kseniya Kobets, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Other Identifiers

2021-13642

Identifier Type: -

Identifier Source: org_study_id