Activated PRP for Treatment of Androgenetic Alopecia

Inclusion criteria

• Male between 30 and 60 years of age, inclusive
• A clinical diagnosis of AGA (stage II to V, according to the Hamilton-Norwood Scale)
• Non-smokers in good general health, as determined by the Investigator
• Willing and able to tolerate multiple injections and attend all study visits
• Willing to maintain the same hair style as at the Screening Visit for the duration of the study
• Willing to have blood drawn.

Exclusion criteria

• Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
• Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
• Current significant skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis) that might interfere with the study conduct or evaluations
• History of surgical correction for hair loss such as transplantation
• Previous exposure to Platelet-rich Plasma (PRP) for alopecia
• Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within 30 days prior to the Screening Visit
• Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine) within 30 days prior to the Screening Visit
• No history of burning, flaking, itching, and stinging of the scalp
• History of malignancy (except basal cell and squamous cell skin cancers) or undergoing chemotherapy or radiation treatments
• A known history of autoimmune thyroid disease, any other thyroid disorder or other autoimmune disorders that in the opinion of the investigator may interfere with the study treatment
• Significant tendency to develop keloids or hypertrophic scarring
• A known history of significant physical or mental disease that the Investigator feels may impact the subject's participation
• The use of aspirin or other NSAIDs (Nonsteroidal anti-inflammatory drugs) such as Nurofen, Voltaren, Diclofenac or Naproxen 7 days before beginning each of the treatments during the study
• The use of Vitamin E supplements (other than in multivitamins) 14 days before beginning each of the treatments during the study
• Current anticoagulant therapy (heparins; factor Xa inhibitors; direct agents such dabigatran, rivaroxaban, apixaban, edoxaban and betrixaban; warfarin/coumarins
• Hereditary or acquired hematological/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia, hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia)
• Utilization of low-level lasers to scalp within 90 days prior to the Screening Visit
• Platelet count of less than 150,000 platelets/µL as measured by automated complete blood cell count and differential at or around the time of treatment (within 3 days of injection)
• Treatment with another investigational drug or other intervention within the previous 180 days
• Current smoker or tobacco use within the previous 2 years