<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02999737</url>
  </required_header>
  <id_info>
    <org_study_id>AGA-2016</org_study_id>
    <nct_id>NCT02999737</nct_id>
  </id_info>
  <brief_title>Comparing Different Platelet Rich Plasma (PRP) Treatment Regimens for Management of Androgenic Alopecia</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Skin Care and Laser Physicians of Beverly Hills</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eclipse Aesthetics, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Skin Care and Laser Physicians of Beverly Hills</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The injection of autologous platelet rich plasma (PRP) is a relatively novel therapy,&#xD;
      generating interest across a wide variety of medical specialties, such as orthopedics,&#xD;
      dentistry, ophthalmology, and dermatology. Several recently published studies have&#xD;
      demonstrated efficacy in treating androgenetic alopecia (aka male or female patterned hair&#xD;
      loss), but each varies in the treatment protocol, and there is no evidence-based data to date&#xD;
      guiding the dosing parameters of and intervals between injection sessions. We propose a&#xD;
      single-center, single-blinded randomized pilot trial to investigate the most beneficial&#xD;
      number and frequency ('schedule') of necessary PRP injections in men and women with&#xD;
      androgenetic alopecia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Androgenetic alopecia is the most common form of hair loss, affecting up to 50% of men and 21&#xD;
      million women in the US alone. Irrespective of gender, balding is known to influence social&#xD;
      interactions and cause substantial emotional distress, especially for those who begin losing&#xD;
      their hair at an early age. Topical minoxidil and oral finasteride are currently the only&#xD;
      Food and Drug Administration (FDA)-approved therapies for androgenetic alopecia in men, and&#xD;
      oral agents are used off-label in women but are contraindicated during pregnancy and&#xD;
      lactation. Response to these therapies varies, and they require continued use to maintain the&#xD;
      benefits. Hair transplantation surgery is a more permanent, yet costly, solution. All of&#xD;
      these treatments carry a risk of undesirable side effects, so there is demand for innovative&#xD;
      new therapeutic options. Autologous platelet rich plasma (PRP) injection is a novel therapy&#xD;
      for the treatment of patterned hair loss, but no studies to date evaluate different treatment&#xD;
      protocols head-to-head. Hence, the purpose of this study is to compare the efficacy of two&#xD;
      different PRP treatment schedules (frequency and number of injection sessions) in men and&#xD;
      women with androgenetic alopecia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent change in terminal hair counts</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluate the mean change in terminal hair counts (hairs/cm2) from baseline at 3 and 6 months after initial platelet rich plasma treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent change in terminal hair shaft caliber</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluate the mean change in terminal hair shaft caliber (microns) from baseline at 3 and 6 months after initial platelet rich plasma treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of hair shedding</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluate the degree of hair shedding from baseline at 3 and 6 months after initial platelet rich plasma treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in investigator assessment of hair growth</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluate changes in the blinded investigator's overall assessment of hair growth from baseline at 3 and 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in subject assessment of hair growth and satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluate changes in the subject's overall assessment of hair growth and satisfaction from baseline at 3 and 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability monitoring</measure>
    <time_frame>6 months</time_frame>
    <description>Monitor for adverse effects from and tolerability of injections</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Androgenetic Alopecia</condition>
  <arm_group>
    <arm_group_label>Platelet Rich Plasma for 4 sessions</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Autologous Platelet Rich Plasma injected in the scalp monthly x 3 then every 3 months x 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Platelet rich plasma for 2 sessions</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Autologous Platelet Rich Plasma injected in the scalp every 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet Rich Plasma for 4 sessions</intervention_name>
    <description>Injection of autologous platelet rich plasma into areas of alopecia on the scalp every month x 3 sessions then every 3 months x 1 session (total 4 sessions)</description>
    <arm_group_label>Platelet Rich Plasma for 4 sessions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet rich plasma for 2 sessions</intervention_name>
    <description>Injection of autologous platelet rich plasma into areas of alopecia on the scalp every 3 months x 2 sessions (total 2 sessions)</description>
    <arm_group_label>Platelet rich plasma for 2 sessions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, aged 18-65 years with AGA&#xD;
&#xD;
          -  Completed and signed consent form&#xD;
&#xD;
          -  Norwood Hamilton stage II-V in men or Ludwig stage I2-II1 in women&#xD;
&#xD;
          -  In general good health&#xD;
&#xD;
          -  Willing and able to attend all study visits&#xD;
&#xD;
          -  Willing to maintain the same hair style and hair care routine as at the screening&#xD;
             visit for the duration of the study&#xD;
&#xD;
          -  Willing to have blood drawn&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years or older than 65 years&#xD;
&#xD;
          -  Diagnosis of alopecia areata or other non-AGA forms of hair loss&#xD;
&#xD;
          -  Current skin disease, cuts, or abrasions on the scalp (i.e. psoriasis, severe&#xD;
             seborrheic dermatitis) that may limit data interpretation or put the subject at&#xD;
             increased risk&#xD;
&#xD;
          -  Scalp infection&#xD;
&#xD;
          -  Malignancy, except for non-scalp nonmelanoma or melanoma skin cancers, or undergoing&#xD;
             chemotherapy or radiation treatments&#xD;
&#xD;
          -  Known history of autoimmune thyroid disease, any other thyroid disorder, or other&#xD;
             autoimmune disorders that may interfere or increase risks associated with the study&#xD;
             treatment&#xD;
&#xD;
          -  Pregnancy, anticipated pregnancy, or breastfeeding&#xD;
&#xD;
          -  Tendency to develop keloids&#xD;
&#xD;
          -  History of surgical correction of hair loss on the scalp&#xD;
&#xD;
          -  Use of products, devices, or medications intended to promote hair growth, except for&#xD;
             subjects whose hair has been stable on FDA-approved therapies (i.e. oral finasteride&#xD;
             and/or topical minoxidil) for 12 months&#xD;
&#xD;
          -  Use of anti-androgenic therapies (i.e. spironolactone, flutamide, cyproterone,&#xD;
             acetate, cimetidine) within 90 days prior to he screening visit&#xD;
&#xD;
          -  Current anticoagulant therapy, except for subjects taking aspirin or other&#xD;
             nonsteroidal anti-inflammatory drugs who are able to interrupt the medication for&#xD;
             seven days before treatment or for subjects taking vitamin E or other over-the-counter&#xD;
             supplements who are able to interrupt the medication for 14 days before treatment&#xD;
&#xD;
          -  Hereditary or acquired hematologic/coagulation disorders including: platelet&#xD;
             dysfunction syndrome or thrombocytopenia (count &lt; 150,000 platelets/Ul),&#xD;
             hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia)&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amelia K Hausauer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skincare and Laser Physicians of Beverly Hills</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Skincare and Laser Physicians of Beverly Hills</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Sinclair R. Male pattern androgenetic alopecia. BMJ. 1998 Sep 26;317(7162):865-9. doi: 10.1136/bmj.317.7162.865. No abstract available.</citation>
    <PMID>9748188</PMID>
  </reference>
  <reference>
    <citation>Cash TF. The psychological effects of androgenetic alopecia in men. J Am Acad Dermatol. 1992 Jun;26(6):926-31. doi: 10.1016/0190-9622(92)70134-2.</citation>
    <PMID>1607410</PMID>
  </reference>
  <reference>
    <citation>Gkini MA, Kouskoukis AE, Tripsianis G, Rigopoulos D, Kouskoukis K. Study of platelet-rich plasma injections in the treatment of androgenetic alopecia through an one-year period. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):213-9. doi: 10.4103/0974-2077.150743.</citation>
    <PMID>25722600</PMID>
  </reference>
  <reference>
    <citation>Gentile P, Garcovich S, Bielli A, Scioli MG, Orlandi A, Cervelli V. The Effect of Platelet-Rich Plasma in Hair Regrowth: A Randomized Placebo-Controlled Trial. Stem Cells Transl Med. 2015 Nov;4(11):1317-23. doi: 10.5966/sctm.2015-0107. Epub 2015 Sep 23.</citation>
    <PMID>26400925</PMID>
  </reference>
  <reference>
    <citation>Alves R, Grimalt R. Randomized Placebo-Controlled, Double-Blind, Half-Head Study to Assess the Efficacy of Platelet-Rich Plasma on the Treatment of Androgenetic Alopecia. Dermatol Surg. 2016 Apr;42(4):491-7. doi: 10.1097/DSS.0000000000000665.</citation>
    <PMID>27035501</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Skin Care and Laser Physicians of Beverly Hills</investigator_affiliation>
    <investigator_full_name>Amelia K Hausauer, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Platelet Rich Plasma</keyword>
  <keyword>PRP</keyword>
  <keyword>Hair loss</keyword>
  <keyword>Alopecia</keyword>
  <keyword>Hypotrichosis</keyword>
  <keyword>Hair diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02999737
org study id: AGA-2016
nct id: NCT02999737
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Percent change in terminal hair counts
time frame: 6 months
description: Evaluate the mean change in terminal hair counts (hairs/cm2) from baseline at 3 and 6 months after initial platelet rich plasma treatment
measure: Percent change in terminal hair shaft caliber
time frame: 6 months
description: Evaluate the mean change in terminal hair shaft caliber (microns) from baseline at 3 and 6 months after initial platelet rich plasma treatment
measure: Degree of hair shedding
time frame: 6 months
description: Evaluate the degree of hair shedding from baseline at 3 and 6 months after initial platelet rich plasma treatment
measure: Changes in investigator assessment of hair growth
time frame: 6 months
description: Evaluate changes in the blinded investigator's overall assessment of hair growth from baseline at 3 and 6 months
measure: Changes in subject assessment of hair growth and satisfaction
time frame: 6 months
description: Evaluate changes in the subject's overall assessment of hair growth and satisfaction from baseline at 3 and 6 months
measure: Safety and tolerability monitoring
time frame: 6 months
description: Monitor for adverse effects from and tolerability of injections
arm group label: Platelet Rich Plasma for 4 sessions
arm group type: Other
description: Autologous Platelet Rich Plasma injected in the scalp monthly x 3 then every 3 months x 1
arm group label: Platelet rich plasma for 2 sessions
arm group type: Other
description: Autologous Platelet Rich Plasma injected in the scalp every 3 months
intervention type: Biological
intervention name: Platelet Rich Plasma for 4 sessions
description: Injection of autologous platelet rich plasma into areas of alopecia on the scalp every month x 3 sessions then every 3 months x 1 session (total 4 sessions)
arm group label: Platelet Rich Plasma for 4 sessions
intervention type: Biological
intervention name: Platelet rich plasma for 2 sessions
description: Injection of autologous platelet rich plasma into areas of alopecia on the scalp every 3 months x 2 sessions (total 2 sessions)
arm group label: Platelet rich plasma for 2 sessions
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Amelia K Hausauer, MD
role: Principal Investigator
affiliation: Skincare and Laser Physicians of Beverly Hills
facility: 
country: United States
citation: Sinclair R. Male pattern androgenetic alopecia. BMJ. 1998 Sep 26;317(7162):865-9. doi: 10.1136/bmj.317.7162.865. No abstract available.
PMID: 9748188
citation: Cash TF. The psychological effects of androgenetic alopecia in men. J Am Acad Dermatol. 1992 Jun;26(6):926-31. doi: 10.1016/0190-9622(92)70134-2.
PMID: 1607410
citation: Gkini MA, Kouskoukis AE, Tripsianis G, Rigopoulos D, Kouskoukis K. Study of platelet-rich plasma injections in the treatment of androgenetic alopecia through an one-year period. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):213-9. doi: 10.4103/0974-2077.150743.
PMID: 25722600
citation: Gentile P, Garcovich S, Bielli A, Scioli MG, Orlandi A, Cervelli V. The Effect of Platelet-Rich Plasma in Hair Regrowth: A Randomized Placebo-Controlled Trial. Stem Cells Transl Med. 2015 Nov;4(11):1317-23. doi: 10.5966/sctm.2015-0107. Epub 2015 Sep 23.
PMID: 26400925
citation: Alves R, Grimalt R. Randomized Placebo-Controlled, Double-Blind, Half-Head Study to Assess the Efficacy of Platelet-Rich Plasma on the Treatment of Androgenetic Alopecia. Dermatol Surg. 2016 Apr;42(4):491-7. doi: 10.1097/DSS.0000000000000665.
PMID: 27035501
responsible party type: Principal Investigator
investigator affiliation: Skin Care and Laser Physicians of Beverly Hills
investigator full name: Amelia K Hausauer, MD
investigator title: Principal Investigator
mesh term: Alopecia
mesh term: Alopecia Areata
sharing ipd: No