Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment 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

Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia

Official Title

Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia

Brief Summary

      The study team will assess the efficacy of platelet-rich plasma therapy, a special blood
      product which is from the participant's own body, in the treatment of androgenic alopecia
      (also known as male pattern hair loss) in females.
    

Detailed Description

      Androgenic alopecia, or male-pattern hair loss affects both men and women. This hair loss
      pattern is typically characterized by thinning at the crown of scalp and/or M-shaped hair
      line in males or diffuse thinning throughout in females. Platelet-rich plasma (PRP) therapy
      has recently been studied as a hair rejuvenation therapy in patients with non-inflammatory
      alopecia. Though the mechanism of action is not well understood, PRP is thought to promote
      angiogenesis and enhance blood flow around hair follicles via platelet-derived growth factor
      (PDGF), transforming growth factor (TGF), and vascular endothelial growth factor (VEGF). The
      primary objective of the study is to determine whether PRP, administered once monthly for 3
      months improves clinical outcomes and quality of life in females with androgenic alopecia.
      This is a randomized, placebo-controlled, double-blind, half-head, single center clinical
      study where sixteen subjects with androgenic alopecia will be recruited. Dermatology Life
      Quality Index will be assessed at several time points. Disease severity will be measured
      using the Severity of Alopecia Tool (SALT), Alopecia Density and Extent Score (ALODEX);
      Trichoscan images will be captured to document participants' clinical progress. Adverse
      events will be recorded at each visit, treatment will be discontinued if any subject
      experience a serious adverse event. Treatment visits will take place at baseline, 4 weeks (1
      month), 8 weeks (2 months), and 12 weeks (3 month). A follow-up, non-treatment visit will
      take place at 24 weeks (6 months). The study team hypothesizes that PRP will improve DLQI,
      SALT, ALODEX, hair count (number of hairs/0.65 cm2), hair density (number of hairs/cm2), hair
      diameter, anagen to telogen ratio, and vellus hair to terminal hair ratio in female subjects
      with androgenic alopecia.
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Change in Severity of Alopecia Tool (SALT) from baseline

Secondary Outcome

 Change in Hair Count (number of hairs/0.65cm^2)

Condition

Androgenic Alopecia

Intervention

Platelet-rich Plasma Left Side

Study Arms / Comparison Groups

 Group A
Description:  At the baseline visit subjects will be randomized to either group A or group B. Group A will receive PRP on left side of scalp and placebo (saline solution) on right side of scalp.

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

16

Start Date

August 2020

Completion Date

February 2021

Primary Completion Date

November 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Female ≥18 years of age at baseline visit.

          -  Documentation of androgenic alopecia diagnosis as evidenced by one or more clinical
             features

          -  Not currently on any treatment for alopecia, or has undergone 2-week washout period if
             recently on medication(s) for alopecia

          -  Written informed consent obtained from subject and ability for subject to comply with
             the requirements of the study

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Presence of a condition or abnormality that in the opinion of the Investigator would
             compromise the safety of the patient or the quality of the data.

          -  Have an infection, metastatic disease or certain skin conditions (ie. Psoriasis) which
             could worsen or spread with injections

          -  Diagnosed with a blood or bleeding disorder

          -  Diagnosed with anemia

          -  Currently on anticoagulant therapy
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Rita Pichardo, MD, 313-716-1773, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03474718

Organization ID

IRB00045844


Responsible Party

Sponsor

Study Sponsor

Wake Forest University Health Sciences


Study Sponsor

Rita Pichardo, MD, Principal Investigator, Wake Forest University School of Medicine, Department of Dermatology


Verification Date

June 2020