Androgenetic AlopeciaPhase 1/2NCT05348343
Activated PRP for Treatment of Androgenetic Alopecia
A Phase 1/2 study testing Autologous platelet-rich plasma in people with Androgenetic Alopecia, run by Santiste Medical Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Autologous platelet-rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2022to 1 Sep 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01803
About this study
Official title: 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.
- Conditions
- Androgenetic Alopecia
- Being tested
- Autologous platelet-rich plasma
- Keywords
- Alopecia, Hair loss, Skin
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous platelet-rich plasmaBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Autocontrolled Arm | Other | The subject will be treated with both the experimental treatment and the active comparator. Receives: Biological: Autologous platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Month 6 and Month 8
Secondary outcomes (2)
Clinical progression of treatment as determined by principal investigator
Global photography evaluation by the PI using Norwood Hamilton scale.
Measured: Month 6 and Month 8
Clinical progression of treatment as determined by subject
Change in reported patient satisfaction outcome surveys.
Measured: Month 6 and Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start17 May 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santiste Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maryanne M. Senna, MD, Principal investigator, Lahey Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348343
- Sponsor's protocol ID
- SM-001
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical 'Proof of Concept' Study of Activated Platelet-rich Plasma (PRP) in Subjects With Androgenetic Alopecia (AGA)
- ClinicalTrials.gov ID
- NCT05348343
- Acronym / sponsor ID
- SM-001
- Conditions
- Androgenetic Alopecia
- Keywords
- Alopecia, Hair loss, Skin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Santiste Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 17 May 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autocontrolled Arm | Other | Biological: Autologous platelet-rich plasmaThe subject will be treated with both the experimental treatment and the active comparator. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous platelet-rich plasmaPRP 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. | Biological | Autocontrolled Arm |
Primary outcome
Change in hair density and hair regrowth
Time frame: 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: 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
Measurement of hair regrowth
Time frame: 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: 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
2 secondary outcomes
Clinical progression of treatment as determined by principal investigator
Time frame: Month 6 and Month 8
Clinical progression of treatment as determined by subject
Time frame: Month 6 and Month 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryanne M. Senna, MD principal investigator
Lahey Hospital & Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous platelet-rich plasma in people with Androgenetic Alopecia, run by Santiste Medical Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hair density and hair regrowth (time frame: Month 6 and Month 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.