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

Not Applicable

Completed

• Conditions: Androgenetic Alopecia
• Interventions: Device: Saline solution injection; Device: Autologous Platelet Rich Plasma

• Registration Number: NCT02591355
• Lead Sponsor: Regen Lab SA

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 Timeline

• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Study Start: 2017-09-06
• Primary Completion: 2019-11-18
• Study Completion: 2019-11-18
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-21
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Saline	Saline solution injection	Saline solution injection
Autologous Platelet Rich Plasma	Autologous Platelet Rich Plasma	Autologous Platelet Rich Plasma injection

Primary Outcome Measures

Name	Time	Method
Evaluate the changes in hair density of androgenetic alopecia	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 Outcome Measures

Name	Time	Method
Evaluate the changes of hair diameter and hair shedding in androgenetic alopecia	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.

Trial Locations

Locations (2)

Axis Clinical Trials; 🇺🇸 Los Angeles, California, United States

NYU Dermatologic Associates; 🇺🇸 New York, New York, United States