Phase
Condition
Hair Loss
Male Pattern Baldness
Alopecia
Treatment
Autologous platelet-rich plasma
Clinical Study ID
Ages 30-60 Male
Study Summary
Eligibility Criteria
Inclusion
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 durationof the study
Willing to have blood drawn.
Exclusion
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 studyconduct 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, cyproteroneacetate, 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) orundergoing chemotherapy or radiation treatments
A known history of autoimmune thyroid disease, any other thyroid disorder or otherautoimmune disorders that in the opinion of the investigator may interfere with thestudy treatment
Significant tendency to develop keloids or hypertrophic scarring
A known history of significant physical or mental disease that the Investigatorfeels may impact the subject's participation
The use of aspirin or other NSAIDs (Nonsteroidal anti-inflammatory drugs) such asNurofen, Voltaren, Diclofenac or Naproxen 7 days before beginning each of thetreatments during the study
The use of Vitamin E supplements (other than in multivitamins) 14 days beforebeginning each of the treatments during the study
Current anticoagulant therapy (heparins; factor Xa inhibitors; direct agents suchdabigatran, rivaroxaban, apixaban, edoxaban and betrixaban; warfarin/coumarins
Hereditary or acquired hematological/coagulation disorders such as: plateletdysfunction syndrome, critical thrombocytopenia, hypofibrinogenemia, impairedcoagulation, 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 completeblood cell count and differential at or around the time of treatment (within 3 daysof injection)
Treatment with another investigational drug or other intervention within theprevious 180 days
Current smoker or tobacco use within the previous 2 years
Study Design
Connect with a study center
Lahey Hospital and Medical Center
Burlington, Massachusetts 01803
United StatesSite Not Available
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