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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
83
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.
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.
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
Hair density
Changes in hair density over time
Time frame: 0 days, 14 days,1 month, 2months,3 months, 6 months
hair density
Changes in hair density over time
Time frame: 0 days, 14days,1 month, 2 months,3 months, 6 months
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