Activated PRP for Treatment of Androgenetic Alopecia
Primary Purpose
Androgenetic Alopecia
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Autologous platelet-rich plasma
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Alopecia, Hair loss, Skin
Eligibility 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
Sites / Locations
- Lahey Hospital and Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Autocontrolled Arm
Arm Description
The subject will be treated with both the experimental treatment and the active comparator.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Clinical progression of treatment as determined by principal investigator
Global photography evaluation by the PI using Norwood Hamilton scale.
Clinical progression of treatment as determined by subject
Change in reported patient satisfaction outcome surveys.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05348343
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santiste Medical Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
Alopecia, Hair loss, Skin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Autocontrolled Arm
Arm Type
Other
Arm Description
The subject will be treated with both the experimental treatment and the active comparator.
Intervention Type
Biological
Intervention Name(s)
Autologous platelet-rich plasma
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in hair density and hair regrowth
Description
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
Time Frame
Month 6 and Month 8
Title
Measurement of hair regrowth
Description
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
Time Frame
Month 6 and Month 8
Secondary Outcome Measure Information:
Title
Clinical progression of treatment as determined by principal investigator
Description
Global photography evaluation by the PI using Norwood Hamilton scale.
Time Frame
Month 6 and Month 8
Title
Clinical progression of treatment as determined by subject
Description
Change in reported patient satisfaction outcome surveys.
Time Frame
Month 6 and Month 8
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Kelley
Phone
781-744-1375
Email
kristen.j.kelley@lahey.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryanne M. Senna, MD
Organizational Affiliation
Lahey Hospital & Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Kelley
Phone
781-744-1375
Email
kristen.j.kelley@lahey.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Activated PRP for Treatment of Androgenetic Alopecia
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