Androgenic AlopeciaPhase 2PRP-AGANCT07348315

Effectiveness of Apheresis Platelet-Rich Plasma Injection for Androgenic Alopecia

A Phase 2 study testing Autologous Apheresis PRP Injection in people with Androgenic Alopecia, run by zhang li at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study was retrospectively registered. The goal of this single-arm, single-center, prospective clinical trial is to evaluate the effectiveness and safety of autologous apheresis platelet-rich plasma (PRP) injection in the treatment of androgenetic alopecia (AGA). Read more about this study

Who is it for?: Ages 18 to 55 years, men only
Conditions the study is for: Androgenic Alopecia
What is being tested?: Autologous Apheresis PRP Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 201 participants
Where: 1 siteChina
Study dates: 1 Sep 2023to 12 Dec 2025
Phase: Phase 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 18 to 55 years
Men only
No healthy volunteers
Adult

Who may be able to join

History of hair loss for more than 6 months
Diagnosed with androgenetic alopecia (AGA) based on the Chinese guideline for diagnosis and treatment of AGA
In good general health with a body weight ≥ 50 kg
No history of hypertension, diabetes, platelet dysfunction, or any other contraindication to PRP apheresis
No use of finasteride, minoxidil, or any other treatment for hair loss within the 6 months preceding enrollment
No recent use of glucocorticoids (topical to treatment site for 1 month; systemic for 2 weeks) prior to PRP apheresis

Show all 12Show fewer

No recent use of nonsteroidal anti-inflammatory drugs (within 48 hours) prior to PRP apheresis
Blood tests within 2 weeks before PRP apheresis meeting the following criteria:
Hemoglobin concentration > 120 g/L
Hematocrit 0.30 to 0.50
Platelet count > 110 × 10^9/L
No clinically significant abnormalities in inflammation, coagulation, or electrolyte panels

Who cannot join

Concurrent use of finasteride, minoxidil, or other hair growth treatments during the PRP treatment phase of the study
Failure to complete a minimum of 3 consecutive PRP treatment sessions as per the study protocol
Failure to complete the required follow-up assessments for any reason

Trial locations and contacts

1 site in 1 country.

China1 site

The General Hospital of Western Theater Command
Chengdu, Sichuan, 610036

Other trials in China

About this study

Official title: Effectiveness of Apheresis Platelet-Rich Plasma Injection for Androgenic Alopecia: A Single-Arm Trial

Is apheresis PRP effective in improving hair growth outcomes in male patients with AGA?
Is treatment response associated with key variables, including patient age, number of treatment sessions, baseline severity, and PRP cellular composition?
Does PRP injection lead to any serious adverse events in the treatment of AGA? Researchers will record the effectiveness and adverse events following autologous apheresis PRP treatment for AGA and perform statistical analyses to evaluate treatment outcomes and their correlates with the variables of interest.

Participants will:

Receive 3 to 5 sessions of autologous apheresis PRP injections into the scalp at intervals of 3-5 weeks.
Have standardized photographs of the scalp taken from four angles (frontal, vertex, and bilateral sides) prior to each PRP injection.
Attend a follow-up clinic visit or complete a telephone assessment one month after the final PRP injection.

Read the detailed description

Androgenetic alopecia (AGA) is a progressive condition with limited optimal therapeutic options. While platelet-rich plasma (PRP) therapy has been explored, the apheresis technique offers a distinct method of PRP preparation that yields higher platelet purity and more consistent cellular composition compared to conventional centrifugation methods. This study is specifically designed to evaluate the clinical effectiveness of this autologous apheresis PRP and identify key predictors. Given the exploratory nature of this investigation aimed at generating preliminary efficacy and safety data for a specific PRP preparation method, a single-arm design was chosen.

The apheresis procedure was performed using a closed-system blood cell separator according to the manufacturer's standardized protocol. All injections were uniformly administered following a strict procedural guideline.

The primary endpoint, change in the BASP classification, was assessed by independent, blinded physicians. The associations between treatment response and key variables, including age, number of sessions, baseline severity, and PRP cellular composition were explored through correlation and regression models.

Conditions: Androgenic Alopecia
Being tested: Autologous Apheresis PRP Injection
Keywords: Androgenetic Alopecia, Platelet-Rich Plasma
Medical subject headings: Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous Apheresis PRP InjectionBiological
Autologous PRP was prepared using a closed-system blood cell separator with disposable blood cell collection consumables, following the manufacturer's standardized protocol.
Using a 30-gauge sterile needle, PRP was administered via intradermal and subcutaneous injections at multiple points across the treatment area, with an injection volume of 0.05 mL per point at intervals of approximately 0.5 cm.
Participants received 3 to 5 sessions of autologous apheresis PRP injections into the scalp at intervals of 3-5 weeks.

Study groups in NCT07348315
Study group	Role	What they receive
Autologous Apheresis PRP Injection	Experimental	All enrolled participants will receive autologous apheresis platelet-rich plasma (PRP) injections into the scalp according to the defined protocol. This is the only arm in this single-arm trial. Receives: Biological: Autologous Apheresis PRP Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Response Based on the Basic and Specific (BASP) classification
The proportion of participants achieving a positive response, defined as an improvement of at least one grade in either the Basic or Specific component of the BASP system, as assessed by blinded, independent physicians on standardized photographs after PRP treatment compared to baseline. As the protocol allows for 3 to 5 injection sessions at intervals of 3 to 5 weeks, the 'End of Treatment' visit occurs on a variable calendar date, falling between Week 9 and Week 25 after the first injection. This design ensures that the assessment captures the cumulative effect of the complete, individualized treatment course for each participant.
Measured: Baseline (pre-first injection) and End of treatment (pre-final injection, ranging from Week 9 to Week 25)

Secondary outcomes (2)

Patient-Reported Improvement Questionnaire
Patient-reported outcomes will be assessed using a four-item questionnaire covering hair quality, hair thickness, hair loss reduction, and overall satisfaction. Responses are recorded on a 3-point scale: -1 (deteriorated/dissatisfied), 0 (unchanged/neutral), +1 (improved/satisfied). The outcome will be reported as the proportion of participants reporting an improvement (score of +1) for each individual item.
Measured: At 1 month after treatment completion
Incidence of treatment-related adverse events.
The frequency and severity of all treatment-related adverse events that occur during the treatment and follow-up period. The incidence will be calculated as the number and percentage of participants experiencing at least one treatment-related adverse event, as well as the number of individual adverse event occurrences.
Measured: From first treatment to 1 month after last treatment, up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202312 Dec 2025

First posted16 Jan 2026
Study start1 Sep 2023
Primary completion1 Sep 2025
Study completion12 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Androgenic 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07348315
Sponsor's protocol ID: 2023xjsxxm-28
Acronym: PRP-AGA
Status last verified: Jan 2026
First submitted: 30 Dec 2025
Last updated: 20 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The individual participant data (IPD) underlying the results of this single-center, investigator-initiated trial are not publicly available due to restrictions in the informed consent documents, which do not explicitly permit public data sharing. Aggregated data supporting the main findings are available within the published article or from the corresponding author upon reasonable request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia

All Androgenic Alopecia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Apheresis Platelet-Rich Plasma Injection for Androgenic Alopecia: A Single-Arm Trial
ClinicalTrials.gov ID: NCT07348315
Acronym / sponsor ID: PRP-AGA / 2023xjsxxm-28
Conditions: Androgenic Alopecia
Keywords: Androgenetic Alopecia, Platelet-Rich Plasma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: zhang liUniversity, hospital or other
Study start: 1 Sep 2023 (actual)
Primary completion: 1 Sep 2025 (actual)
Study completion: 12 Dec 2025 (actual)
First posted: 16 Jan 2026 (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.

Is apheresis PRP effective in improving hair growth outcomes in male patients with AGA?
Is treatment response associated with key variables, including patient age, number of treatment sessions, baseline severity, and PRP cellular composition?
Does PRP injection lead to any serious adverse events in the treatment of AGA? Researchers will record the effectiveness and adverse events following autologous apheresis PRP treatment for AGA and perform statistical analyses to evaluate treatment outcomes and their correlates with the variables of interest.

Participants will:

Receive 3 to 5 sessions of autologous apheresis PRP injections into the scalp at intervals of 3-5 weeks.
Have standardized photographs of the scalp taken from four angles (frontal, vertex, and bilateral sides) prior to each PRP injection.
Attend a follow-up clinic visit or complete a telephone assessment one month after the final PRP injection.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Autologous Apheresis PRP Injection	Experimental	Biological: Autologous Apheresis PRP InjectionAll enrolled participants will receive autologous apheresis platelet-rich plasma (PRP) injections into the scalp according to the defined protocol. This is the only arm in this single-arm trial.

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

History of hair loss for more than 6 months
Diagnosed with androgenetic alopecia (AGA) based on the Chinese guideline for diagnosis and treatment of AGA
In good general health with a body weight ≥ 50 kg
No history of hypertension, diabetes, platelet dysfunction, or any other contraindication to PRP apheresis
No use of finasteride, minoxidil, or any other treatment for hair loss within the 6 months preceding enrollment

Key exclusion criteria (3 listed)

Concurrent use of finasteride, minoxidil, or other hair growth treatments during the PRP treatment phase of the study
Failure to complete a minimum of 3 consecutive PRP treatment sessions as per the study protocol
Failure to complete the required follow-up assessments for any reason

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 Apheresis PRP InjectionAutologous PRP was prepared using a closed-system blood cell separator with disposable blood cell collection consumables, following the manufacturer's standardized protocol. Using a 30-gauge sterile needle, PRP was administered via intradermal and subcutaneous injections at multiple points across the treatment area, with an injection volume of 0.05 mL per point at intervals of approximately 0.5 cm. Participants received 3 to 5 sessions of autologous apheresis PRP injections into the scalp at intervals of 3-5 weeks.	Biological	Autologous Apheresis PRP Injection

Primary outcome

Response Based on the Basic and Specific (BASP) classification
Time frame: Baseline (pre-first injection) and End of treatment (pre-final injection, ranging from Week 9 to Week 25)
The proportion of participants achieving a positive response, defined as an improvement of at least one grade in either the Basic or Specific component of the BASP system, as assessed by blinded, independent physicians on standardized photographs after PRP treatment compared to baseline. As the protocol allows for 3 to 5 injection sessions at intervals of 3 to 5 weeks, the 'End of Treatment' visit occurs on a variable calendar date, falling between Week 9 and Week 25 after the first injection. This design ensures that the assessment captures the cumulative effect of the complete, individualized treatment course for each participant.

2 secondary outcomes

Patient-Reported Improvement Questionnaire
Time frame: At 1 month after treatment completion
Incidence of treatment-related adverse events.
Time frame: From first treatment to 1 month after last treatment, up to 6 months

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 20 Jan 2026.
Individual participant dataSharing planned: No. The individual participant data (IPD) underlying the results of this single-center, investigator-initiated trial are not publicly available due to restrictions in the informed consent documents, which do not explicitly permit public data sharing. Aggregated data supporting the main findings are available within the published article or from the corresponding author upon reasonable request.

Related trials for Androgenic Alopecia

Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous Apheresis PRP Injection in people with Androgenic Alopecia, run by zhang li at 1 site in China.

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 12 inclusion and 3 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 20 Jan 2026. 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 China. 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 phase mean?

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?

Response Based on the Basic and Specific (BASP) classification (time frame: Baseline (pre-first injection) and End of treatment (pre-final injection, ranging from Week 9 to Week 25)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07348315.

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 20 Jan 2026.