Activated PRP for Treatment of Androgenetic Alopecia

Androgenetic Alopecia Clinical Trial

Official title:

A Pilot Clinical 'Proof of Concept' Study of Activated Platelet-rich Plasma (PRP) in Subjects With Androgenetic Alopecia (AGA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05348343
• Other study ID #: SM-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 17, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2022
• Source: Santiste Medical Inc.
• Contact: Kristen Kelley
• Phone: 781-744-1375
• Email: kristen.j.kelley[@]lahey.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Santiste Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hair density and hair regrowth	The change in hair density (hair count and thickness) measured in the region of interest (ROI) at six months and eight months using automated image analysis with Trichovision/Fotofinder imaging software. The change will be compared to the following: Baseline in the same ROI; An entire treatment area with diagnosed AGA on the scalp; The same region on the contralateral scalp	Month 6 and Month 8
Primary	Measurement of hair regrowth	The amount of hair regrowth measured in the region of interest (ROI) at six months and eight months using automated image analysis with Trichovision/Fotofinder imaging software. The change will be compared to the following: Baseline in the same ROI; An entire treatment area with diagnosed AGA on the scalp; The same region on the contralateral scalp	Month 6 and Month 8
Secondary	Clinical progression of treatment as determined by principal investigator	Global photography evaluation by the PI using Norwood Hamilton scale.	Month 6 and Month 8
Secondary	Clinical progression of treatment as determined by subject	Change in reported patient satisfaction outcome surveys.	Month 6 and Month 8