Activated PRP for Treatment of Androgenetic Alopecia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Biological: Autologous platelet-rich plasma

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Kristen Kelley; Phone Number: 781-744-1375; Email: kristen.j.kelley@lahey.org

Study Locations

• United States
  • Massachusetts
    • Burlington, Massachusetts, United States, 01803
      • Recruiting
      • Lahey Hospital and Medical Center
      • Contact: Kristen Kelley; Phone Number: 781-744-1375; Email: kristen.j.kelley@lahey.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Autocontrolled Arm; The subject will be treated with both the experimental treatment and the active comparator.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical progression of treatment as determined by principal investigator	Global photography evaluation by the PI using Norwood Hamilton scale.	Month 6 and Month 8
Clinical progression of treatment as determined by subject	Change in reported patient satisfaction outcome surveys.	Month 6 and Month 8

Collaborators and Investigators

• Sponsor: Santiste Medical Inc.
• Investigators: Principal Investigator: Maryanne M. Senna, MD, Lahey Hospital & Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2022
• Primary Completion (ANTICIPATED): January 31, 2023
• Study Completion (ANTICIPATED): March 31, 2023

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (ACTUAL): April 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Skin; Alopecia; Hair loss
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: SM-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No