Efficacy and Safety of Platelet Rich Plasma in Androgenetic Alopecia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Vancouver General Hospital
Sponsor:
Information provided by (Responsible Party):
Jerry Shapiro, Vancouver General Hospital
ClinicalTrials.gov Identifier:
NCT02074943
First received: February 25, 2014
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Androgenetic Alopecia
Biological: Platelet rich plasma

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Platelet Rich Plasma in Androgenetic Alopecia: A Double-Blind, Randomized, Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Vancouver General Hospital:

Primary Outcome Measures:
  • The degree of hair regrowth based on the hair regrowth score (RGS) for each side of scalp. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in hair count and caliber. Changes in hair count and caliber [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Half head injected with normal saline
Active Comparator: Half head inject with platelet rich plasma Biological: Platelet rich plasma

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02074943

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

Locations
Canada
The Skin Care Center, Vancouver General Hospital Not yet recruiting
Vancouver, Canada, V5Z 4E8
Contact: Jerry Shapiro, MD    604-875-5151    Jerry.Shapiro@vch.ca   
Sponsors and Collaborators
Vancouver General Hospital
  More Information

No publications provided

Responsible Party: Jerry Shapiro, Clinical Professor, Vancouver General Hospital
ClinicalTrials.gov Identifier: NCT02074943     History of Changes
Other Study ID Numbers: H13-03126
Study First Received: February 25, 2014
Last Updated: February 26, 2014
Health Authority: Canada: Health Canada

Keywords provided by Vancouver General Hospital:
Androgenetic Alopecia

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014