Skip to main content
OpenTrials
Completed

NCT Number: NCT02591355

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Axis Clinical Trials, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Platelet Rich Plasma

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 solution injection

Device

Placebo is a saline solution

Primary outcomes

  1. Evaluate the changes in hair density of androgenetic alopecia

    Time frame: 5 months

    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 outcomes

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

    Time frame: 5 months

    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.

Sponsors and collaborators

Lead sponsor

Regen Lab SA

Industry

Collaborators

  • RegenLab USA LLC

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2015
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.