Activated PRP for Treatment of Androgenetic Alopecia

NCT ID: NCT05348343

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2023-09-01

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 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.

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autocontrolled Arm

The subject will be treated with both the experimental treatment and the active comparator.

Group Type: OTHER

Autologous platelet-rich plasma

Intervention Type: BIOLOGICAL

PRP created using a commercially available system will be used for treatment. PEFA-PRP will be created by subjecting PRP to a pulsed electrical field in a specially designed instrument developed by sponsor. Two 9 cm2 contralateral regions of interest (ROI) on the scalp will be treated with approximately 6mL of either PRP or PEFA-PRP by subcutaneous injection.

Interventions

Autologous platelet-rich plasma

PRP created using a commercially available system will be used for treatment. PEFA-PRP will be created by subjecting PRP to a pulsed electrical field in a specially designed instrument developed by sponsor. Two 9 cm2 contralateral regions of interest (ROI) on the scalp will be treated with approximately 6mL of either PRP or PEFA-PRP by subcutaneous injection.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 duration of the study

6. Willing to have blood drawn.

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 study conduct 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, cyproterone acetate, 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) or undergoing chemotherapy or radiation treatments

10. 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

11. Significant tendency to develop keloids or hypertrophic scarring

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

13. 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

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

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

16. Hereditary or acquired hematological/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia, hypofibrinogenemia, impaired coagulation, 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 complete blood cell count and differential at or around the time of treatment (within 3 days of injection)

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

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Santiste Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maryanne M. Senna, MD

Role: PRINCIPAL_INVESTIGATOR

Lahey Hospital & Medical Center

Locations

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Countries

United States

Other Identifiers

SM-001

Identifier Type: -

Identifier Source: org_study_id