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

Primary Purpose

Androgenetic Alopecia

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Fractionated Thulium laser

Autologous Platelet Rich Plasma Injection

Autologous Platelet Rich Plasma Topical Application

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring alopecia, laser, platelet rich plasma, male pattern hair loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

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

Platelet rich plasma injection

Arm 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 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.

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.

Outcomes

Primary Outcome Measures

Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at month 7 follow-up.

Clinician Global Aesthetic Improvement Scale (CGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth. Greatly decreased (-3) Moderately decreased (-2) Slightly decreased (-1) No change (0) Slightly increased (+1) Moderately increased (+2) 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.

Percentage of subjects with score of 2 or 3 on Subject Global Aesthetic Improvement at month 7 follow-up.

Subject Global Aesthetic Improvement Scale (SGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth. Greatly decreased (-3) Moderately decreased (-2) Slightly decreased (-1) No change (0) Slightly increased (+1) Moderately increased (+2) 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.

Secondary Outcome Measures

Percentage of subjects with score of 2 or 3 on Patient Satisfaction Questionnaire at month 7 follow-up.

Patient Satisfaction Questionnaire will use Lickert scale, ranging from "greatly decreased (-3)" to "greatly increased (+3)". Greatly decreased (-3) Moderately decreased (-2) Slightly decreased (-1) No change (0) Slightly increased (+1) Moderately increased (+2) Greatly increased (+3) The seven point Lickert scale will apply to following patient satisfaction questions: Please choose the option that better represents the change in how your hair looks OVERALL in the area treated? Please choose the option that better represents the change in your hair THICKNESS in the area treated? Please choose the option that better represents the change in your hair SHEDDING/LOSS in the area treated? Please choose the option that better represents the change in your hair DARKNESS in the area treated.

Reported pain score on Numeric Rating Scale for Pain for first 4 months during treatment

The Numeric Rating Scale for Pain is an 11-point scale scored from 0-10, with 0 = no pain, 5 = moderate pain, and 10 = worst possible pain. Subjects select a value that is most in line with the intensity of their pain experienced during and after treatment with Thulium Laser and topical platelet rich plasma or platelet rich plasma injection. The NRS pain questionnaire will be given to participants to complete for each treatment for the first 4 months of the study.

Full Information

NCT ID

NCT05129254

First Posted

November 10, 2021

Last Updated

August 2, 2022

Sponsor

Montefiore Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05129254

Brief Title

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

Official Title

A Pilot Study Evaluating the Safety and Efficacy of a Fractionated Thulium Laser and Topical Platelet Rich Plasma vs. Platelet Rich Plasma Injection for the Treatment of Male Androgenetic Alopecia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Study not initiated.

Study Start Date

July 1, 2022 (Anticipated)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Androgenetic Alopecia

Keywords

alopecia, laser, platelet rich plasma, male pattern hair loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

To compare the efficacy of laser to improve delivery of topical platelet rich plasma (PRP) to promote hair growth, the investigators will employ a randomized, unblinded, baseline-controlled study design. There will be two parallel treatment arms in the study. The first arm will enroll six participants to receive thulium laser and topical PRP. The second arm will enroll six participants to receive PRP injection alone. Total participants enrolled will be twelve (12). There will be a total of 8 study visits (4 treatment and 4 follow-up) lasting 16 months. Each participant will receive an initial series of 4 treatments, either laser + topical PRP or PRP injection alone once a month for the first 4 months (month 1, 2, 3, 4). Thereafter, patients will be followed at 3-month intervals at month 7, 10, 13, and 16.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

Platelet rich plasma injection

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Fractionated Thulium laser

Other Intervention Name(s)

LaseMD Lutronic Laser

Intervention Description

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

Procedure

Intervention Name(s)

Autologous Platelet Rich Plasma Injection

Intervention Description

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

Intervention Name(s)

Autologous Platelet Rich Plasma Topical Application

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at month 7 follow-up.

Description

Time Frame

7 months

Title

Percentage of subjects with score of 2 or 3 on Subject Global Aesthetic Improvement at month 7 follow-up.

Description

Time Frame

7 months

Secondary Outcome Measure Information:

Title

Percentage of subjects with score of 2 or 3 on Patient Satisfaction Questionnaire at month 7 follow-up.

Description

Time Frame

7 months

Title

Reported pain score on Numeric Rating Scale for Pain for first 4 months during treatment

Description

Time Frame

4 months

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male with biopsy proven diagnosis of androgenetic alopecia

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kseniya Kobets, MD

Organizational Affiliation

Montefiore Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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