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

RegenLab

Status: Completed

Conditions: Androgenetic Alopecia

Treatments: Device: Saline solution injection; Device: Autologous Platelet Rich Plasma

Study type: Interventional

Funder types: Industry

Identifiers

NCT02591355

RL 03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Autologous Platelet Rich Plasma

Experimental group

Description:

Autologous Platelet Rich Plasma injection

Treatment:

Device: Autologous Platelet Rich Plasma

Saline

Placebo Comparator group

Description:

Saline solution injection

Treatment:

Device: Saline solution injection