Many people suffer from alopecia, which is caused by hereditary factors, emotional stress, and psychiatric disorders. There are devastating physical and psychological consequences as a result. Exosomes are isolated from donated human mesenchymal stem cells and purified using specific processing. This study is a randomized, double-blind, dose-escalation clinical trial designed to evaluate the efficacy and safety of exosomes therapy for alopecia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
Shenzhen Qianhai Shekou Free Trade Zone Hospital
Shenzhen, Guangdong, China
Comparison of localized hair density
Quantify hair counts within designated 1.5 cm × 1.5 cm fixed areas in both the study area and control area, and compare the localized hair density (hair/cm²) between the two areas.
Time frame: 3rd month after 3 treatments
Safety Assessment
Incidence of treatment emergent adverse events (TEAEs)
Time frame: From the initial treatment administration to the subject withdrawal from the study.
Comparison of overall hair density
Evaluate and score overall hair density in both the study area and control area using an 8-level assessment scale, followed by a comparative analysis of the two areas.
Time frame: 3rd month after 3 treatments
Change of hair density
Change in hair density of study area with the baseline.
Time frame: 3rd and 6st month after 3 treatments
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