Activated PRP for Treatment of Androgenetic Alopecia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Change in hair density and hair regrowth [Month 6 and Month 8]
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
- Measurement of hair regrowth [Month 6 and Month 8]
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
Secondary Outcome Measures
- Clinical progression of treatment as determined by principal investigator [Month 6 and Month 8]
Global photography evaluation by the PI using Norwood Hamilton scale.
- Clinical progression of treatment as determined by subject [Month 6 and Month 8]
Change in reported patient satisfaction outcome surveys.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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
-
Hereditary or acquired hematological/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia, hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia)
-
Utilization of low-level lasers to scalp within 90 days prior to the Screening Visit
-
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)
-
Treatment with another investigational drug or other intervention within the previous 180 days
-
Current smoker or tobacco use within the previous 2 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lahey Hospital and Medical Center | Burlington | Massachusetts | United States | 01803 |
Sponsors and Collaborators
- Santiste Medical Inc.
Investigators
- Principal Investigator: Maryanne M. Senna, MD, Lahey Hospital & Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SM-001