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Efficacy and Safety of Platelet Rich Plasma in Androgenetic Alopecia

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ClinicalTrials.gov Identifier: NCT02074943
Recruitment Status : Unknown
Verified December 2014 by Jerry Shapiro, Vancouver General Hospital.
Recruitment status was:  Recruiting
First Posted : February 28, 2014
Last Update Posted : December 11, 2014
Information provided by (Responsible Party):
Jerry Shapiro, Vancouver General Hospital

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

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Biological: PRP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Platelet Rich Plasma in Androgenetic Alopecia: A Double-Blind, Randomized, Placebo Controlled Trial
Study Start Date : April 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PRP/Saline
Same patient will be injected with PRP and normal saline. Each one will be inject on half head.
Biological: PRP
PRP will be inject to half head. The other half will be injected with normal saline.

Primary Outcome Measures :
  1. The degree of hair regrowth based on the hair regrowth score (RGS) for each side of scalp. [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Changes in hair count and caliber. Changes in hair count and caliber [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02074943

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Contact: Jerry Shapiro, MD 604-875-5151 Jerry.Shapiro@vch.ca

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The Skin Care Center, Vancouver General Hospital Recruiting
Vancouver, Canada, V5Z 4E8
Contact: Jerry Shapiro, MD    604-875-5151    Jerry.Shapiro@vch.ca   
Sponsors and Collaborators
Vancouver General Hospital
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Principal Investigator: Jerry Shapiro, MD Professor
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jerry Shapiro, Clinical Professor, Vancouver General Hospital
ClinicalTrials.gov Identifier: NCT02074943    
Other Study ID Numbers: H13-03126
First Posted: February 28, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014
Keywords provided by Jerry Shapiro, Vancouver General Hospital:
Androgenetic Alopecia
Additional relevant MeSH terms:
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Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical