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

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

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.

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Device: Autologous Platelet Rich Plasma; Device: Saline solution injection

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
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
  • New York
    • New York, New York, United States, 10016
      • NYU Dermatologic Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Autologous Platelet Rich Plasma; Autologous Platelet Rich Plasma injection	Device: Autologous Platelet Rich Plasma; Autologous Platelet Rich Plasma a novel therapeutic modality used in numerous applications. 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.
PLACEBO_COMPARATOR: Saline; Saline solution injection	Device: Saline solution injection; Placebo is a saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the changes in hair density of androgenetic alopecia	Evaluate split scalp changes in hair density of androgenetic alopecia after 5 month treatment of Autologous Platelet Rich Plasma prepared with the RegenBCT-1 kit compared to other half of the scalp treated with saline solution.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the changes of hair diameter and hair shedding in androgenetic alopecia	Evaluate the changes of hair diameter and hair shedding in androgenetic alopecia after 5 months treatment of Autologous Platelet Rich Plasma prepared with the RegenBCT-1 kit compared to other half of the scalp treated with saline solution.	5 months

Collaborators and Investigators

• Sponsor: Regen Lab SA
• Collaborators: RegenLab USA LLC
• Investigators: Principal Investigator: Jerry Shapiro, MD, NYU School of Medicine, Langone Medical Center, New-York University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 6, 2017
• Primary Completion (ACTUAL): November 18, 2019
• Study Completion (ACTUAL): November 18, 2019

Study Registration Dates

• First Submitted: October 28, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (ESTIMATE): October 29, 2015

Study Record Updates

• Last Update Posted (ACTUAL): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 21, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Hair Loss; Platelet Rich Plasma
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: RL 03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No