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Efficacy and Safety of Platelet Rich Plasma in Androgenetic Alopecia

Primary Purpose

Androgenetic Alopecia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PRP
Sponsored by
Vancouver General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Androgenetic Alopecia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Skin Care Center, Vancouver General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRP/Saline

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 25, 2014
Last Updated
December 10, 2014
Sponsor
Vancouver General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02074943
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vancouver General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
Androgenetic Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRP/Saline
Arm Type
Experimental
Arm Description
Same patient will be injected with PRP and normal saline. Each one will be inject on half head.
Intervention Type
Biological
Intervention Name(s)
PRP
Intervention Description
PRP will be inject to half head. The other half will be injected with normal saline.
Primary Outcome Measure Information:
Title
The degree of hair regrowth based on the hair regrowth score (RGS) for each side of scalp.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Changes in hair count and caliber. Changes in hair count and caliber
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jerry Shapiro, MD
Phone
604-875-5151
Email
Jerry.Shapiro@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Shapiro, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Skin Care Center, Vancouver General Hospital
City
Vancouver
ZIP/Postal Code
V5Z 4E8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerry Shapiro, MD
Phone
604-875-5151
Email
Jerry.Shapiro@vch.ca

12. IPD Sharing Statement

Citations:
PubMed Identifier
31984508
Citation
Siah TW, Guo H, Chu T, Santos L, Nakamura H, Leung G, Shapiro J, McElwee KJ. Growth factor concentrations in platelet-rich plasma for androgenetic alopecia: An intra-subject, randomized, blinded, placebo-controlled, pilot study. Exp Dermatol. 2020 Mar;29(3):334-340. doi: 10.1111/exd.14074. Epub 2020 Feb 7.
Results Reference
derived

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Efficacy and Safety of Platelet Rich Plasma in Androgenetic Alopecia

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