Status:
COMPLETED
Activated PRP for Treatment of Androgenetic Alopecia
Lead Sponsor:
Santiste Medical Inc.
Conditions:
Androgenetic Alopecia
Eligibility:
MALE
30-60 years
Phase:
PHASE1
PHASE2
Brief Summary
A clinical trial to assess the effects and safety of PRP activated with pulsed electrical fields (PEFA-PRP) compared with unactivated PRP when used to treat AGA. The design of this small-scale, phase...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05348343
Start Date
May 17 2022
End Date
September 1 2023
Last Update
April 27 2025
Active Locations (1)
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1
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01803