Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment

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Brief Title

Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment

Official Title

A Monocentric, Double-blind, Randomized, Active- and Placebo-controlled Split-scalp Study to Evaluate the Clinical Effectiveness of Platelet-rich Plasma (PRP) in the Treatment of Androgenetic Alopecia

Brief Summary

      Platelet rich plasma (PRP) therapy is a novel therapeutic modality that has seen broad
      applications for a number of medical indications including those in orthopedics, dentistry,
      and dermatology. In dermatology, its uses have included treatment of chronic wounds and
      facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the
      treatment of hair loss, but to the best of our knowledge, there has been only one published
      case series documenting its use for this indication.
    

Detailed Description

      This study was designed to better assess the efficacy of PRP in hair loss, we therefore
      propose to study interval intralesional PRP injections for patients with androgenetic
      alopecia (AGA). Androgenetic alopecia is the most common form of hair loss world-wide.
      Although there are currently numerous treatment options for this indication including
      minoxidil, 5-alpha reductase inhibitors and follicular unit transplant, many of the medical
      treatment options have undesirable side effects, particularly in women of child bearing age.
      These well-documented adverse reactions include impotency, hypertrichosis, and birth defects.
    


Study Type

Interventional


Primary Outcome

Evaluate the changes in hair density of androgenetic alopecia

Secondary Outcome

 Evaluate the changes of hair diameter and hair shedding in androgenetic alopecia

Condition

Androgenetic Alopecia

Intervention

Autologous Platelet Rich Plasma

Study Arms / Comparison Groups

 Autologous Platelet Rich Plasma
Description:  Autologous Platelet Rich Plasma injection

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

Device

Estimated Enrollment

80

Start Date

September 6, 2017

Completion Date

November 18, 2019

Primary Completion Date

November 18, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Men and women, age 18-60 with AGA

          -  Completed informed consent form

          -  Ludwig stage 1-2 for women

          -  Norwood Hamilton Stage 3 to 5 for men

        Exclusion Criteria:

          -  Pregnancy or breastfeeding

          -  Younger than 18 years

          -  Uses of minoxidil and/or 5-alpha reductase inhibitors (such as finasteride or
             dutasteride) within 3 months of enrolling in the study

          -  History of hair transplantation

          -  Use of any cosmetic product aimed at improving or correcting the signs of hair loss
             within 2 weeks prior to screening

          -  Facial cancer (squamous and basal cell carcinoma, melanoma)

          -  Hereditary or acquired hematologic/coagulation disorders such as: platelet dysfunction
             syndrome, critical thrombocytopenia, hypofibrinogenemia, impaired coagulation,
             drepanocytosis (sickle cell anemia).

          -  Hemodynamic instability

          -  Acute infection

          -  Auto-immune disease such as Hashimoto, rheumatoid arthritis, or lupus (exception:
             vitiligo and alopecia areata)

          -  Malignancy with or without metastatic disease

          -  Chemotherapy

          -  Dermatological diseases affecting the face (e.g. porphyria)

          -  Anticoagulant therapy

          -  Patients taking Aspirin or other NSAIDs (Nonsteroidal anti-inflammatory drugs) such as
             Nurofen, Voltaren, Diclofenac or Naproxen can participate, provided medication is
             interrupted 7 days before beginning of the treatment

          -  Patients taking vitamin E supplements can participate, provided medication is
             interrupted 14 days before beginning of the treatment
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Jerry Shapiro, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02591355

Organization ID

RL 03


Responsible Party

Sponsor

Study Sponsor

Regen Lab SA

Collaborators

 RegenLab USA LLC

Study Sponsor

Jerry Shapiro, MD, Principal Investigator, NYU School of Medicine, Langone Medical Center, New-York University


Verification Date

December 2019