Comparing Different Platelet Rich Plasma (PRP) Treatment Regimens for Management of Androgenic Alopecia

Learn more about:
Related Clinical Trial
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

Comparing Different Platelet Rich Plasma (PRP) Treatment Regimens for Management of Androgenic Alopecia

Official Title

Evaluating the Efficacy of Different Platelet Rich Plasma (PRP) Treatment Regimens in the Management of Androgenetic Alopecia: an Investigator-initiated, Single-center, Single-blinded, Prospective, Randomized Clinical Trial

Brief Summary

      The injection of autologous platelet rich plasma (PRP) is a relatively novel therapy,
      generating interest across a wide variety of medical specialties, such as orthopedics,
      dentistry, ophthalmology, and dermatology. Several recently published studies have
      demonstrated efficacy in treating androgenetic alopecia (aka male or female patterned hair
      loss), but each varies in the treatment protocol, and there is no evidence-based data to date
      guiding the dosing parameters of and intervals between injection sessions. We propose a
      single-center, single-blinded randomized pilot trial to investigate the most beneficial
      number and frequency ('schedule') of necessary PRP injections in men and women with
      androgenetic alopecia.
    

Detailed Description

      Androgenetic alopecia is the most common form of hair loss, affecting up to 50% of men and 21
      million women in the US alone. Irrespective of gender, balding is known to influence social
      interactions and cause substantial emotional distress, especially for those who begin losing
      their hair at an early age. Topical minoxidil and oral finasteride are currently the only
      Food and Drug Administration (FDA)-approved therapies for androgenetic alopecia in men, and
      oral agents are used off-label in women but are contraindicated during pregnancy and
      lactation. Response to these therapies varies, and they require continued use to maintain the
      benefits. Hair transplantation surgery is a more permanent, yet costly, solution. All of
      these treatments carry a risk of undesirable side effects, so there is demand for innovative
      new therapeutic options. Autologous platelet rich plasma (PRP) injection is a novel therapy
      for the treatment of patterned hair loss, but no studies to date evaluate different treatment
      protocols head-to-head. Hence, the purpose of this study is to compare the efficacy of two
      different PRP treatment schedules (frequency and number of injection sessions) in men and
      women with androgenetic alopecia.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Percent change in terminal hair counts

Secondary Outcome

 Percent change in terminal hair shaft caliber

Condition

Androgenetic Alopecia

Intervention

Platelet Rich Plasma for 4 sessions

Study Arms / Comparison Groups

 Platelet Rich Plasma for 4 sessions
Description:  Autologous Platelet Rich Plasma injected in the scalp monthly x 3 then every 3 months x 1

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

Biological

Estimated Enrollment

40

Start Date

November 2016

Completion Date

August 2017

Primary Completion Date

August 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female, aged 18-65 years with AGA

          -  Completed and signed consent form

          -  Norwood Hamilton stage II-V in men or Ludwig stage I2-II1 in women

          -  In general good health

          -  Willing and able to attend all study visits

          -  Willing to maintain the same hair style and hair care routine as at the screening
             visit for the duration of the study

          -  Willing to have blood drawn

        Exclusion Criteria:

          -  Younger than 18 years or older than 65 years

          -  Diagnosis of alopecia areata or other non-AGA forms of hair loss

          -  Current skin disease, cuts, or abrasions on the scalp (i.e. psoriasis, severe
             seborrheic dermatitis) that may limit data interpretation or put the subject at
             increased risk

          -  Scalp infection

          -  Malignancy, except for non-scalp nonmelanoma or melanoma skin cancers, or undergoing
             chemotherapy or radiation treatments

          -  Known history of autoimmune thyroid disease, any other thyroid disorder, or other
             autoimmune disorders that may interfere or increase risks associated with the study
             treatment

          -  Pregnancy, anticipated pregnancy, or breastfeeding

          -  Tendency to develop keloids

          -  History of surgical correction of hair loss on the scalp

          -  Use of products, devices, or medications intended to promote hair growth, except for
             subjects whose hair has been stable on FDA-approved therapies (i.e. oral finasteride
             and/or topical minoxidil) for 12 months

          -  Use of anti-androgenic therapies (i.e. spironolactone, flutamide, cyproterone,
             acetate, cimetidine) within 90 days prior to he screening visit

          -  Current anticoagulant therapy, except for subjects taking aspirin or other
             nonsteroidal anti-inflammatory drugs who are able to interrupt the medication for
             seven days before treatment or for subjects taking vitamin E or other over-the-counter
             supplements who are able to interrupt the medication for 14 days before treatment

          -  Hereditary or acquired hematologic/coagulation disorders including: platelet
             dysfunction syndrome or thrombocytopenia (count < 150,000 platelets/Ul),
             hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia)

          -  Hemodynamic instability
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Amelia K Hausauer, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02999737

Organization ID

AGA-2016


Responsible Party

Principal Investigator

Study Sponsor

Skin Care and Laser Physicians of Beverly Hills

Collaborators

 Eclipse Aesthetics, LLC

Study Sponsor

Amelia K Hausauer, MD, Principal Investigator, Skincare and Laser Physicians of Beverly Hills


Verification Date

January 2017