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

Primary Purpose

Androgenetic Alopecia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Autologous Platelet Rich Plasma
Saline solution injection
Sponsored by
Regen Lab SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Platelet Rich Plasma, Hair Loss

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Axis Clinical Trials
  • NYU Dermatologic Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Autologous Platelet Rich Plasma

Saline

Arm Description

Autologous Platelet Rich Plasma injection

Saline solution injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 28, 2015
Last Updated
December 21, 2019
Sponsor
Regen Lab SA
Collaborators
RegenLab USA LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02591355
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
November 18, 2019 (Actual)
Study Completion Date
November 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regen Lab SA
Collaborators
RegenLab USA LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
Platelet Rich Plasma, Hair Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous Platelet Rich Plasma
Arm Type
Experimental
Arm Description
Autologous Platelet Rich Plasma injection
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline solution injection
Intervention Type
Device
Intervention Name(s)
Autologous Platelet Rich Plasma
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Saline solution injection
Intervention Description
Placebo is a saline solution
Primary Outcome Measure Information:
Title
Evaluate the changes in hair density of androgenetic alopecia
Description
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.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Evaluate the changes of hair diameter and hair shedding in androgenetic alopecia
Description
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.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Shapiro, MD
Organizational Affiliation
NYU School of Medicine, Langone Medical Center, New-York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
NYU Dermatologic Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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