Androgenetic Alopecia (AGA)Phase 2AGANCT07335367
PRP Combined With Botulinum Toxin Type A Injection for the Treatment of Androgenetic Alopecia: A Study
A Phase 2 study testing Injection of PRP combined with Botulinum Toxin Type A into the alopecic area(s) and PRP-only injection into the alopecic area in people with Androgenetic Alopecia (AGA), run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Research Purpose The objective of this study is to determine the safety and efficacy of combined PRP and BTX-A injection therapy for Androgenetic Alopecia (AGA). Study Content This clinical trial is a randomized (1:1), multicenter, parallel-group, controlled study. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Androgenetic Alopecia (AGA)
- What is being tested?
- Injection of PRP combined with Botulinum Toxin Type A into the alopecic area(s) and PRP-only injection into the alopecic area
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2026to 20 Aug 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who meet the diagnostic criteria for AGA, confirmed by medical history, clinical presentation, and trichoscopy, with a stage of Norwood-Hamilton III to V or Ludwig I to III.
- Patients provide informed consent and voluntarily participate in the study.
- A signed informed consent form is obtained.
- Age between 18 and 60 years, in good general health.
- No use of any medications for AGA treatment within the past 6 months.
- Absence of alopecia areata, local infection, or neuromuscular diseases.
Who cannot join
- Disease duration exceeding 5 years.
- Patients who do not meet the diagnostic criteria for AGA.
- Individuals with coagulation disorders.
- Patients with active skin diseases or other severe systemic illnesses.
- Patients with blood-borne infectious diseases such as Hepatitis A, Hepatitis B, HIV/AIDS, or Syphilis.
- Use of any medications for hair loss treatment within the past 6 months.
- Other conditions deemed by the investigator as unsuitable for participation, including but not limited to unreliable patients, or those unable to undergo or comprehend the study assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Research Purpose
The objective of this study is to determine the safety and efficacy of combined PRP and BTX-A injection therapy for Androgenetic Alopecia (AGA).
Read more
Study Content
This clinical trial is a randomized (1:1), multicenter, parallel-group, controlled study. AGA patients aged 18 to 60 years presenting to the participating centers will be recruited. After providing informed consent, eligible patients who meet the inclusion/exclusion criteria will be randomized in a 1:1 ratio, with separate randomization schedules for male and female patients, into either the experimental group (PRP combined with BTX-A injection) or the control group (PRP injection only). A total of 76 patients will be enrolled.
Control Group: Subjects randomized to the control group will receive PRP injection therapy. The PRP will be administered intradermally (at a depth of approximately 1.5-2.5 mm, with injection points 1 cm apart) into the scalp area (defined as ≥12 cm from the lateral canthus and ≥9 cm from the top of the ear, encompassing the frontal, temporal, parietal, and occipital regions) at a dose of 0.1 ml/cm². The treatment regimen consists of monthly injections, 4 ml per session, for a total of 3 consecutive sessions.
Experimental Group: Subjects randomized to the experimental group will receive injections using the same method and frequency as the control group. For the first session, the injection will consist of 100U of BTX-A reconstituted in 4 ml of PRP. The second and third sessions will be identical to those in the control group (PRP injection only).
Follow-up Assessments: For all subjects, a safety evaluation will be conducted 14 days after the first treatment, along with scalp care guidance provided by the investigator. Subsequent safety and efficacy assessments will be performed at 1, 2, 3, and 6 months following the initial treatment.
- Conditions
- Androgenetic Alopecia (AGA)
- Being tested
- Injection of PRP combined with Botulinum Toxin Type A into the alopecic area(s), PRP-only injection into the alopecic area
- Keywords
- 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.
Injection of PRP combined with Botulinum Toxin Type A into the alopecic area(s)Combination product
Treatment Protocol:
Subjects in the PRP combined with Botulinum Toxin Type A (BTX-A) treatment group received injections using the same method and frequency as the PRP control group. For the first session, the injection consisted of 100 units of BTX-A reconstituted in 4 ml of PRP. The second and third sessions were identical to those administered to the control group (PRP injection only).
Follow-up Assessments:
A safety evaluation was conducted for each subject 14 days after the initial treatment, during which the investigator provided scalp care guidance. Subsequent evaluations for both safety and efficacy were performed at 1, 2, 3, and 6 months following the initial treatment.
PRP-only injection into the alopecic areaOther
Treatment Protocol for the PRP-Only Control Group:
Subjects in the PRP-only control group will receive PRP injection therapy alone. The PRP will be administered intradermally at a depth of approximately 1.5-2.5 mm, with injection points spaced 1 cm apart, into the predefined scalp area (≥12 cm from the lateral canthus and ≥9 cm from the top of the ear, encompassing the frontal, temporal, parietal, and occipital regions). The injections will be administered at a dose of 0.1 ml/cm². The treatment regimen consists of monthly sessions, with 4 ml of PRP injected per session, for a total of 3 consecutive sessions.
Follow-up Assessments:
A safety evaluation will be conducted for each subject 14 days after the initial treatment, during which the investigator will provide personalized scalp care guidance. Subsequent comprehensive assessments evaluating both safety and efficacy will be performed at 1, 2, 3, and 6 months following the initial treatment.
| Study group | Role | What they receive |
|---|---|---|
| PRP combined with Botulinum Toxin Type A treatment group | Experimental | Not described Receives: Combination Product: Injection of PRP combined with Botulinum Toxin Type A into the alopecic area(s) |
| PRP-only control group | Active comparator | Not described Receives: Other: PRP-only injection into the alopecic area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair density
Changes in hair density over time
Measured: 0 days, 14 days,1 month, 2months,3 months, 6 months
hair density
Changes in hair density over time
Measured: 0 days, 14days,1 month, 2 months,3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start9 Jan 2026
- Primary completion5 Aug 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic Alopecia (AGA)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335367
- Sponsor's protocol ID
- NFEC-2025-311
- Acronym
- AGA
- Status last verified
- Sep 2026
- First submitted
- 5 Jan 2026
- Last updated
- 9 Sep 2026
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRP Combined With Botulinum Toxin Type A Injection for the Treatment of Androgenetic Alopecia: A Study
- ClinicalTrials.gov ID
- NCT07335367
- Acronym / sponsor ID
- AGA / NFEC-2025-311
- Conditions
- Androgenetic Alopecia (AGA)
- Keywords
- Platelet-Rich Plasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 13 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.
Research Purpose
The objective of this study is to determine the safety and efficacy of combined PRP and BTX-A injection therapy for Androgenetic Alopecia (AGA).
Study Content
This clinical trial is a randomized (1:1), multicenter, parallel-group, controlled study. AGA patients aged 18 to 60 years presenting to the participating centers will be recruited. After providing informed consent, eligible patients who meet the inclusion/exclusion criteria will be randomized in a 1:1 ratio, with separate randomization schedules for male and female patients, into either the experimental group (PRP combined with BTX-A injection) or the control group (PRP injection only). A total of 76 patients will be enrolled.
Control Group: Subjects randomized to the control group will receive PRP injection therapy. The PRP will be administered intradermally (at a depth of approximately 1.5-2.5 mm, with injection points 1 cm apart) into the scalp area (defined as ≥12 cm from the lateral canthus and ≥9 cm from the top of the ear, encompassing the frontal, temporal, parietal, and occipital regions) at a dose of 0.1 ml/cm². The treatment regimen consists of monthly injections, 4 ml per session, for a total of 3 consecutive sessions.
Experimental Group: Subjects randomized to the experimental group will receive injections using the same method and frequency as the control group. For the first session, the injection will consist of 100U of BTX-A reconstituted in 4 ml of PRP. The second and third sessions will be identical to those in the control group (PRP injection only).
Follow-up Assessments: For all subjects, a safety evaluation will be conducted 14 days after the first treatment, along with scalp care guidance provided by the investigator. Subsequent safety and efficacy assessments will be performed at 1, 2, 3, and 6 months following the initial treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP combined with Botulinum Toxin Type A treatment group | Experimental | Combination Product: Injection of PRP combined with Botulinum Toxin Type A into the alopecic area(s) |
| PRP-only control group | Active comparator | Other: PRP-only injection into the alopecic area |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients who meet the diagnostic criteria for AGA, confirmed by medical history, clinical presentation, and trichoscopy, with a stage of Norwood-Hamilton III to V or Ludwig I to III.
- Patients provide informed consent and voluntarily participate in the study.
- A signed informed consent form is obtained.
- Age between 18 and 60 years, in good general health.
- No use of any medications for AGA treatment within the past 6 months.
Key exclusion criteria (7 listed)
- Disease duration exceeding 5 years.
- Patients who do not meet the diagnostic criteria for AGA.
- Individuals with coagulation disorders.
- Patients with active skin diseases or other severe systemic illnesses.
- Patients with blood-borne infectious diseases such as Hepatitis A, Hepatitis B, HIV/AIDS, or Syphilis.
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 |
|---|---|---|
| Injection of PRP combined with Botulinum Toxin Type A into the alopecic area(s)Treatment Protocol: Subjects in the PRP combined with Botulinum Toxin Type A (BTX-A) treatment group received injections using the same method and frequency as the PRP control group. For the first session, the injection consisted of 100 units of BTX-A reconstituted in 4 ml of PRP. The second and third sessions were identical to those administered to the control group (PRP injection only). Follow-up Assessments: A safety evaluation was conducted for each subject 14 days after the initial treatment, during which the investigator provided scalp care guidance. Subsequent evaluations for both safety and efficacy were performed at 1, 2, 3, and 6 months following the initial treatment. | Combination product | PRP combined with Botulinum Toxin Type A treatment group |
| PRP-only injection into the alopecic areaTreatment Protocol for the PRP-Only Control Group: Subjects in the PRP-only control group will receive PRP injection therapy alone. The PRP will be administered intradermally at a depth of approximately 1.5-2.5 mm, with injection points spaced 1 cm apart, into the predefined scalp area (≥12 cm from the lateral canthus and ≥9 cm from the top of the ear, encompassing the frontal, temporal, parietal, and occipital regions). The injections will be administered at a dose of 0.1 ml/cm². The treatment regimen consists of monthly sessions, with 4 ml of PRP injected per session, for a total of 3 consecutive sessions. Follow-up Assessments: A safety evaluation will be conducted for each subject 14 days after the initial treatment, during which the investigator will provide personalized scalp care guidance. Subsequent comprehensive assessments evaluating both safety and efficacy will be performed at 1, 2, 3, and 6 months following the initial treatment. | Other | PRP-only control group |
Primary outcome
Hair density
Time frame: 0 days, 14 days,1 month, 2months,3 months, 6 months
Changes in hair density over time
hair density
Time frame: 0 days, 14days,1 month, 2 months,3 months, 6 months
Changes in hair density over time
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 9 Sep 2026.
- 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.
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 Injection of PRP combined with Botulinum Toxin Type A into the alopecic area(s) and PRP-only injection into the alopecic area in people with Androgenetic Alopecia (AGA), run by Nanfang Hospital, Southern Medical University 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 6 inclusion and 7 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 9 Sep 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?
Hair density (time frame: 0 days, 14 days,1 month, 2months,3 months, 6 months). 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 9 Sep 2026.