Activated PRP for Treatment of Androgenetic Alopecia

Last updated: April 23, 2025
Sponsor: Santiste Medical Inc.
Overall Status: Completed

Phase

1/2

Condition

Hair Loss

Male Pattern Baldness

Alopecia

Treatment

Autologous platelet-rich plasma

Clinical Study ID

NCT05348343
SM-001
  • Ages 30-60
  • Male

Study 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 1b/2a clinical trial is to demonstrate that pulsed electric field activation of autologous PRP results in a controlled release of platelet growth factors and other biologically active molecules that will have a benefit effect on the non-cycling hair follicles in the treated scalp compared to non-activated PRP. This single-center, auto-controlled study will compare the clinical benefit of PEFA-PRP versus non-activated PRP treatment of male patients with AGA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male between 30 and 60 years of age, inclusive

  2. A clinical diagnosis of AGA (stage II to V, according to the Hamilton-Norwood Scale)

  3. Non-smokers in good general health, as determined by the Investigator

  4. Willing and able to tolerate multiple injections and attend all study visits

  5. Willing to maintain the same hair style as at the Screening Visit for the durationof the study

  6. Willing to have blood drawn.

Exclusion

Exclusion Criteria:

  1. Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia

  2. Scalp hair loss on the treatment area, due to disease, injury, or medical therapy

  3. Current significant skin disease (e.g., psoriasis, atopic dermatitis, skin cancer,eczema, sun damage, seborrheic dermatitis) that might interfere with the studyconduct or evaluations

  4. History of surgical correction for hair loss such as transplantation

  5. Previous exposure to Platelet-rich Plasma (PRP) for alopecia

  6. 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

  7. Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproteroneacetate, cimetidine) within 30 days prior to the Screening Visit

  8. No history of burning, flaking, itching, and stinging of the scalp

  9. History of malignancy (except basal cell and squamous cell skin cancers) orundergoing chemotherapy or radiation treatments

  10. 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

  11. Significant tendency to develop keloids or hypertrophic scarring

  12. A known history of significant physical or mental disease that the Investigatorfeels may impact the subject's participation

  13. 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

  14. The use of Vitamin E supplements (other than in multivitamins) 14 days beforebeginning each of the treatments during the study

  15. Current anticoagulant therapy (heparins; factor Xa inhibitors; direct agents suchdabigatran, rivaroxaban, apixaban, edoxaban and betrixaban; warfarin/coumarins

  16. Hereditary or acquired hematological/coagulation disorders such as: plateletdysfunction syndrome, critical thrombocytopenia, hypofibrinogenemia, impairedcoagulation, drepanocytosis (sickle cell anemia)

  17. Utilization of low-level lasers to scalp within 90 days prior to the Screening Visit

  18. 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)

  19. Treatment with another investigational drug or other intervention within theprevious 180 days

  20. Current smoker or tobacco use within the previous 2 years

Study Design

Total Participants: 17
Treatment Group(s): 1
Primary Treatment: Autologous platelet-rich plasma
Phase: 1/2
Study Start date:
May 17, 2022
Estimated Completion Date:
September 01, 2023

Connect with a study center

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts 01803
    United States

    Site Not Available

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