Activated PRP for Treatment of Androgenetic Alopecia

NCT05348343 | Completed Phase 1

• 1 other identifier: SM-001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Keywords

Alopecia; Hair loss; Skin

Outcome Measures

Primary Outcomes (2)

• 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: 1. Baseline in the same ROI 2. An entire treatment area with diagnosed AGA on the scalp 3. 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: 1. Baseline in the same ROI 2. An entire treatment area with diagnosed AGA on the scalp 3. The same region on the contralateral scalp

  Month 6 and Month 8

Secondary Outcomes (2)

• Clinical progression of treatment as determined by principal investigator

  Month 6 and Month 8

• Clinical progression of treatment as determined by subject

  Month 6 and Month 8

Study Arms (1)

Autocontrolled Arm

OTHER

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

Biological: Autologous platelet-rich plasma

Interventions

Autologous platelet-rich plasma 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.

Autocontrolled Arm

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Santiste Medical Inc.: lead

Study Sites (1)

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01803, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Maryanne M. Senna, MD

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 27, 2022
• Study Start: May 17, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)