Clinical trial NCT05348343: Activated PRP for Treatment of Androgenetic Alopecia
Official title: A Pilot Clinical 'Proof of Concept' Study of Activated Platelet-rich Plasma (PRP) in Subjects With Androgenetic Alopecia (AGA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Androgenetic Alopecia
Keywords: Alopecia
Hair loss
Skin
Lead sponsor: Santiste Medical Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-27
Enrollment: 17
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in hair density and hair regrowth
timeFrame: Month 6 and Month 8
measure: Measurement of hair regrowth
timeFrame: Month 6 and Month 8
Secondary outcomes:
measure: Clinical progression of treatment as determined by principal investigator
timeFrame: Month 6 and Month 8
measure: Clinical progression of treatment as determined by subject
timeFrame: Month 6 and Month 8
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
Study officials:
affiliation: Lahey Hospital & Medical Center
name: Maryanne M. Senna, MD
role: PRINCIPAL_INVESTIGATOR
References: