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

Learn more about:
Related Clinical Trial
Efficacy of Platelet-Rich Plasma Versus Mesotherapy in Androgenetic Alopecia: A Retrospective Study Thulium Laser and Topical Platelet Rich Plasma (PRP) vs. PRP Injection for the Treatment of Male Androgenetic Alopecia Safety, Tolerability and Pharmacokinetics of KX826 in Healthy Male Subjects With Androgenetic Alopecia Following Topical Single Ascending Dose Administration A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001 Association of Androgenetic Alopecia and Severity of Coronavirus Disease 2019 (COVID-19). Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia Androgenetic Alopecia Treatment Using Varin and Cannabidiol Rich Topical Hemp Oil: A Case Series A Study to Evaluate the Efficacy and Safety of AD-208 A Phase 2a Trial of FOL-005 Topical Formulations to Investigate Hair Growth Potential and Safety in Healthy Male Volunteers Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia Low Level Light Device as a Primary Therapy for Androgenetic Alopecia the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending Topical Cetirizine in Androgenetic Alopecia in Females A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Male Subjects With Hair Loss A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Female Subjects With Hair Loss Anti-Androgen Treatment for COVID-19 A Study to Evaluate the Superiority, Efficacy and Tolerability of Combination Pantovigar With 2% Minoxidil vs 2% Minoxidil in Women With Female Pattern Hair Loss The Effect of Platelet Rich Plasma on Non-scarring Alopecia Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter HairDx Analytical Validation Study The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002899) A Study to Evaluate and Compare Injections of Autologous Dermal Cells Into the Balding Scalp of Subjects With Hair Loss A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002013) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002012) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0006931) A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0005995) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004669) A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004542) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004541) To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study To Evaluate the Pharmacokinetics and Safety of AD-208 The Utility of Platelet Rich Plasma in Hair Loss Computer-Assisted Versus Manual Hair Harvest Comparative Study Topical Bimatoprost Effect on Androgen Dependent Hair Follicles Efficacy Study of Minoxidil Lotion Versus Combined Minoxidil and Finasteride Lotion to Treat Male Pattern Hair Loss A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512) PAI-1 Expression in Non-scarring Hair Loss Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia Cold Plasma to Treat Hair Loss Adipose-derived SVF for Treatment of Alopecia Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss Photosensitization Study in Androgenetic Alopecia Point-of-Care Adipose-derived Cells for Hair Growth Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application Modulated Light Therapy in Participants With Pattern Hair Loss Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia N-Acetyl-Cysteine for Treatment of AGA in Men Clinical Trial in Females for Female Pattern Hair Loss Effects of Finasteride on Serum Prostate-Specific Antigen (0906-111) Effect of Pumpkin Seed Oil on Hair Growth in Men With Androgenetic Alopecia Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5% Treatment of Androgenetic Alopecia in Males and Females Microarray Analysis of Scalp Biopsies After Minoxidil Treatment Efficacy of Platelet-Rich Plasma Therapy for Androgenetic Alopecia: A Systematic Review and Meta-analysis 24 Week Clinical Trial to Evaluate Safety and Effectiveness of a Hair Growth System to Treat Male and Female Baldness A Randomized, Double-blind Clinical Trial to Evaluate the Safety and Efficacy of the X5 HairLaser for the Treatment of Androgenetic Alopecia in Males Dose-Ranging Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss Minoxidil Response Testing in Males With Androgenetic Alopecia Follicular Revival in Androgenic Alopecia: Evaluating Use of Micro-needling A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy Study To Determine Safety & Efficacy Of Autologous Human Platelet Lysate in Androgenetic Alopecia After Hair Transplant Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia Study to Assess Efficacy of Platelet-Rich Plasma in Androgenetic Alopecia The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA) Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution Treatment of Androgenetic Alopecia in Females, 9 Beam Treatment of Androgenetic Alopecia in Males With Theradome™ LH80 PRO Comparing Different Platelet Rich Plasma (PRP) Treatment Regimens for Management of Androgenic Alopecia Local Pharmacokinetics and Tolerability of Bimatoprost Applied to the Scalp of Male Patients With Androgenetic Alopecia Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia Safety and Efficacy of Hair Stimulating Complex (HSC) on Hair Growth in Males With Androgenetic Alopecia Hair Growth Efficacy and Safety of NGF-574H in Adult With Androgenic Alopecia Plasma Rich in Growth Factors (PRGF-Endoret)in the Treatment of Androgenetic Alopecia Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia Efficacy and Safety Study to Compare Two Minoxidil Formulations on Women With Androgenetic Alopecia A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing Treatment of Androgenetic Alopecia in Males Adipose Derived Stem Cells Versus Platelet Rich Plasma on Follicular Unit Extraction Treatment of Androgenetic Alopecia in Females, 12 Beam Nanofat Grafting for Treatment of Androgenetic Alopecia Topical Cetirizine 1% vs Minoxidil 5% Gel in Treatment of Androgenetic Alopecia Efficacy Study of a Cosmetic Lotion in the Treatment of Androgenetic Alopecia in Males and Females Treatment of Androgenic Alopecia in Males A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia Androgenetic Alopecia and the JAK-STAT Pathway Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment Efficacy and Safety of Platelet Rich Plasma in Androgenetic Alopecia The Effect of Platelet-rich Plasma in Subjects With Androgenetic Alopecia

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

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.
    


Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Androgenetic Alopecia

Intervention

Fractionated Thulium laser

Study Arms / Comparison Groups

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

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

12

Start Date

February 1, 2022

Completion Date

December 31, 2025

Primary Completion Date

December 31, 2024

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.
      

Gender

Male

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Kseniya Kobets, MD, 7189208352, [email protected]



Administrative Informations


NCT ID

NCT05129254

Organization ID

Male Androgenetic Alopecia


Responsible Party

Principal Investigator

Study Sponsor

Montefiore Medical Center


Study Sponsor

Kseniya Kobets, MD, Principal Investigator, Montefiore Medical Center


Verification Date

November 2021