PRP plus botulinum toxin A injections for androgenetic hair loss

PRP Combined With Botulinum Toxin Type A Injection for the Treatment of Androgenetic Alopecia: A Study

This trial will test whether adding botulinum toxin type A to platelet-rich plasma (PRP) injections helps adults aged 18–60 with androgenetic alopecia regrow hair better than PRP alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07335367 on ClinicalTrials.gov

What this trial studies

This phase 2, randomized (1:1), parallel-group controlled trial will enroll 76 adults with androgenetic alopecia and randomize them, with separate schedules for men and women, to receive either intradermal PRP combined with botulinum toxin type A or PRP alone. Treatments are delivered as intradermal scalp injections (approximately 1.5–2.5 mm depth, injection points about 1 cm apart) targeting affected areas, and the study will monitor safety and hair-regrowth outcomes. Eligible patients meet Norwood-Hamilton III–V or Ludwig I–III criteria and must not have used hair-loss medications in the prior 6 months; key exclusions include long disease duration, coagulation disorders, active infections, blood-borne infectious diseases, and neuromuscular conditions. The trial is led by Nanfang Hospital, Southern Medical University in Guangzhou and compares combination therapy against PRP alone to see if the addition of botulinum toxin provides extra benefit.

Who should consider this trial

Good fit: Adults 18–60 years old with androgenetic alopecia at Norwood-Hamilton III–V or Ludwig I–III stages, in good general health and off hair-loss medications for at least 6 months, are the intended participants.

Not a fit: Individuals with disease duration over 5 years, non-AGA hair loss, coagulation disorders, active systemic or scalp infections, blood-borne infections, recent hair-loss treatments, or neuromuscular disease are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the combination could produce greater hair regrowth than PRP alone and offer a new treatment option for people with AGA.

How similar studies have performed: Small trials and case series have shown that PRP can improve hair density in AGA, but combining PRP with botulinum toxin is relatively novel and supported only by limited preliminary evidence.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Patients provide informed consent and voluntarily participate in the study.
3. A signed informed consent form is obtained.
4. Age between 18 and 60 years, in good general health.
5. No use of any medications for AGA treatment within the past 6 months.
6. Absence of alopecia areata, local infection, or neuromuscular diseases.

Exclusion Criteria:

1. Disease duration exceeding 5 years.
2. Patients who do not meet the diagnostic criteria for AGA.
3. Individuals with coagulation disorders.
4. Patients with active skin diseases or other severe systemic illnesses.
5. Patients with blood-borne infectious diseases such as Hepatitis A, Hepatitis B, HIV/AIDS, or Syphilis.
6. Use of any medications for hair loss treatment within the past 6 months.
7. 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.

Where this trial is running

Guangzhou, Guangdong

• Nanfang Hospital Southern Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Yong Miao, MD, PhD

Conditions Androgenetic Alopecia; Platelet-Rich Plasma