机构地区：[1]Stempeutics Research Pvt. Ltd., 3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd., Bengaluru, India [2]Stempeutics Research Pvt. Ltd., 4th Floor, Shirdi Sai Baba Cancer Hospital, Manipal, India
出 处：《Journal of Cosmetics, Dermatological Sciences and Applications》2023年第3期182-208,共27页化妆品、皮肤病及应用期刊（英文）
摘 要：Background and Aims: Androgenetic alopecia (AGA) is a common form of hair loss in both men and women. Despite its high prevalence and associated patient morbidity, the approved therapeutic options are limited to finasteride and minoxidil. The present study is aimed at assessing the efficacy of hair serum formulation, Trichosera<sup>®</sup>containing Bone marrow-derived mesenchymal stromal cells conditioned media as an active ingredient, for hair fall control and hair regrowth in healthy Indian human volunteers. Methods: The product was made using a 20% concentration of 10X Conditioned Media along with excipients. The final product was tested for physicochemical parameters, biomarkers, total protein content and microbial limits as per our in-house specifications. Results: The primary irritation patch test showed that the product is non-irritant and dermatologically safe. A clinical study on 40 subjects was conducted to evaluate the effectiveness of the bioactive formulation in hair fall control and hair regrowth in healthy volunteers. Phototrichogram measurement showed hair density and hair growth rate increased significantly by 11.54% and 18.66% at week 24. Hair tensile strength also increased significantly by 41.10% at 12 weeks follow-up. Hair pull test, to see a reduction in pulled hair and comb’s test to show a decrease in hair fall significantly improved from week 4 onwards. There were no significant adverse events in response to the product application. Conclusion: It is concluded that the hair serum product is completely safe on direct application to the scalp and showed significant improvement in the hair growth rate, hair density, scalp condition and reduction in hair fall. .Background and Aims: Androgenetic alopecia (AGA) is a common form of hair loss in both men and women. Despite its high prevalence and associated patient morbidity, the approved therapeutic options are limited to finasteride and minoxidil. The present study is aimed at assessing the efficacy of hair serum formulation, Trichosera<sup>®</sup>containing Bone marrow-derived mesenchymal stromal cells conditioned media as an active ingredient, for hair fall control and hair regrowth in healthy Indian human volunteers. Methods: The product was made using a 20% concentration of 10X Conditioned Media along with excipients. The final product was tested for physicochemical parameters, biomarkers, total protein content and microbial limits as per our in-house specifications. Results: The primary irritation patch test showed that the product is non-irritant and dermatologically safe. A clinical study on 40 subjects was conducted to evaluate the effectiveness of the bioactive formulation in hair fall control and hair regrowth in healthy volunteers. Phototrichogram measurement showed hair density and hair growth rate increased significantly by 11.54% and 18.66% at week 24. Hair tensile strength also increased significantly by 41.10% at 12 weeks follow-up. Hair pull test, to see a reduction in pulled hair and comb’s test to show a decrease in hair fall significantly improved from week 4 onwards. There were no significant adverse events in response to the product application. Conclusion: It is concluded that the hair serum product is completely safe on direct application to the scalp and showed significant improvement in the hair growth rate, hair density, scalp condition and reduction in hair fall. .
关 键 词：Trichosera® Bone Marrow Derived Mesenchymal Stromal Cells Conditioned Media Hair Fall Hair Regrowth Human Volunteer Study
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