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

NCT ID: NCT02591355

Last Updated: 2019-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-06
• Study Completion Date: 2019-11-18

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.

Conditions

Androgenetic Alopecia

Keywords

Platelet Rich Plasma; Hair Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Autologous Platelet Rich Plasma

Autologous Platelet Rich Plasma injection

Group Type: EXPERIMENTAL

Autologous Platelet Rich Plasma

Intervention Type: DEVICE

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.

Saline

Saline solution injection

Group Type: PLACEBO_COMPARATOR

Saline solution injection

Intervention Type: DEVICE

Placebo is a saline solution

Interventions

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.

Intervention Type: DEVICE

Saline solution injection

Placebo is a saline solution

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RegenLab USA LLC

INDUSTRY

Sponsor Role: collaborator

Regen Lab SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerry Shapiro, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine, Langone Medical Center, New-York University

Locations

Axis Clinical Trials

Los Angeles, California, United States

NYU Dermatologic Associates

New York, New York, United States

Countries

United States

Other Identifiers

RL 03

Identifier Type: -

Identifier Source: org_study_id