Efficacy and Safety of Platelet Rich Plasma in Androgenetic Alopecia

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Brief Title

Efficacy and Safety of Platelet Rich Plasma in Androgenetic Alopecia

Official Title

Efficacy and Safety of Platelet Rich Plasma in Androgenetic Alopecia: A Double-Blind, Randomized, Placebo Controlled Trial

Brief Summary

      The investigators plan to conduct a clinical trial to assess the effects and safety of
      platelet rich plasma on androgenetic alopecia.
    

Detailed Description

      Platelet rich plasma (PRP) is made from your own blood by taking a sample of venous blood,
      placing it in a special tube, and spinning the blood in a centrifuge which is a piece of
      equipment used to separate the components of blood. Blood is made of red blood cells, white
      blood cells and platelets, while plasma, the liquid component is predominantly water but also
      contains clotting factors, proteins, and glucose. Platelets are small, disk shaped clear cell
      fragments which are a natural source of growth factors. They circulate in the blood and are
      involved in hemostasis which is a process which causes bleeding to stop, leading to the
      formation of blood clots. So-called "Platelet-rich plasma" represents the patient's own
      plasma that has been mechanically centrifuged to increase the concentration of platelets
      compared to the whole blood. The basic idea behind PRP injection is to deliver high
      concentrations of growth factors to the scalp, with the hope of stimulating hair regrowth.

      PRP is an innovative therapy and has been used since 1987 to help promote healing in
      orthopedic surgery, dental surgery and dermatology. Recently, there have been reports
      supporting the use of PRP in the treatment of hair loss.

      Androgenetic alopecia (AGA) is the most common cause of hair loss. It has very limited
      treatment modalities which includes minoxidil, 5-alpha reductase inhibitors and hair
      transplantation. Each option has its own side effects range from hypertrichosis which is
      excessive hair growth, possible birth defects if given to women of child bearing age,
      decreased libido and the possibility of prolonged impotence.

      To our best knowledge, there are no double blind, randomized, placebo-controlled trials
      evaluating the efficacy and safety of PRP injection in treating AGA. A placebo is a simulated
      or otherwise medically ineffectual treatment for a disease or other medical condition
      intended to deceive the recipient. The investigators plan to conduct a clinical trial to
      assess the effects and safety of PRP on AGA. The investigators also plan to identify the
      presence of various growth factors in PRP and their correlations in hair regrowth.
    


Study Type

Interventional


Primary Outcome

The degree of hair regrowth based on the hair regrowth score (RGS) for each side of scalp.

Secondary Outcome

 Changes in hair count and caliber. Changes in hair count and caliber

Condition

Androgenetic Alopecia

Intervention

PRP

Study Arms / Comparison Groups

 PRP/Saline
Description:  Same patient will be injected with PRP and normal saline. Each one will be inject on half head.

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

20

Start Date

April 2014

Completion Date

December 2015

Primary Completion Date

June 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Males and females in good general health, ages 18-70.

          -  Patients with mild to moderate AGA (Ludwig alopecia score I and II, and the
             Hamilton-Norwood score 1 to 4).

        Exclusion Criteria:

          -  Patients who received treatments for AGA within the last 3 months.

          -  Patients who have active or history of malignancies.

          -  Patients with platelets disorders, anemia and or bleeding disorders.

          -  Women who are pregnant or breast-feeding.

          -  Un-cooperative patients or patients who are unable to understand the protocol or give
             informed consent.

          -  Patients who are known to be HIV, hepatitis B or C positive or otherwise
             immunocompromised.

          -  Subjects who have active skin disease or skin infection at the intended treatment
             area.

          -  Patients on non-steroidal anti-inflammatory medications.

          -  Patients with a propensity for keloids.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jerry Shapiro, MD, 604-875-5151, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02074943

Organization ID

H13-03126


Responsible Party

Principal Investigator

Study Sponsor

Vancouver General Hospital


Study Sponsor

Jerry Shapiro, MD, Principal Investigator, Professor


Verification Date

December 2014