The significant differences in RMVs between the test and control groups were observed after 6 weeks of treatment, both in the primary ITT and OT populations. The incidence of patients with AEs was not significantly different between the test and control groups.
Asparagus racemosus root extract was entrapped in hydroxypropyl-β-cyclodextrin (HPβCD) by a physical mixing method and then incorporated in an oil in water (o/w) emulsion to evaluate its stability and clinical effectiveness. After the emulsion containing the HPβCD-entrapped extract was kept at 45.0 ± 2.0°C for 90 days, 90% of saponins, major compounds of the extract, remained. Without entrapment with HPβCD, the amount of saponins would have decreased to 10% after storage for 60 days. After application of the emulsion containing the entrapped extract or the unentrapped extract to the outermost layer of full thickness skin, about 38% of saponins could penetrate into the skin. A higher amount of saponins was accumulated in the outermost layer applied with emulsion containing the entrapped extract. For a clinical study, measurement of the surface evaluation of wrinkles (SEw) at the zygomatic area of the face was measured at weeks 8 and 12. The average SEw value of group of subjects that applied the extract-free emulsion was significantly higher than that of the group that applied the emulsion containing the entrapped extract (p < 0.05). Our study indicates that in o/w emulsion, saponins in A. racemosus root extract could maintain their stability after entrapping the extract within HPβCD. Moreover, the effectiveness of the entrapped extract on prevention of wrinkle progression was seen.
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