84 HYGIENE CONTROL RED KAPOK FLOWER POLYSACCHARIDES 0.5% 10000x 10000x
Figure 2: Scanning electron microscopy of the surface of reconstituted vaginal epithelia colonized by L. crispatus and L. gasseri (Magnification 5000x and 10000x)
could thus promote communication with the host in favour of a prebiotic and protective effect.
Clinical study These results were confirmed by a clinical study performed on 5 women groups n=60 (1: post-vaginosis, 2: post-mycosis, 3: irritation, 4: post-menopause active’ and 5: post-menopause control). The women of groups 1 to 4 used on their intimate area, a cleansing gel once a day and a cream twice a day formulated with red kapok flower polysaccharides 1.25% for 28 days. The women of group 5 used on their intimate
area, a control cleansing gel once a day and a control cream twice a day formulated without the active ingredient for 28 days. The following were analyzed for each
parameter: the variation between D0 and D28 for each group and groups 1 to 4 altogether; and the difference in variation between D0 and D28 for group 4 active compared with group 5 control.
Anti-inflammatory and prebiotic effect The inflammatory marker (cytokine IL1a) and lactobacillus measurement were performed from vulvar swabs. The inflammatory marker analyzed by ELISA from the swab showed a significant reduction (IL1a -9.5%**) after 28 days with the active ingredient compared to D0 when groups 1 to 4 were combined. The active ingredient provides an overall improvement in the inflammatory state of the
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%
Control
Glucose 2% RKFP 0.125% RKFP 0.25% RKFP 0.5% RKFP 1%
Lactic acid (nmol/µL)
25421.81 ± 4389.11
24200.96 ± 1062.12
57556.58 ± 29969.59
46584.36 ± 2749.86
48314.47 ± 12267.67
90768.17 ± 945.72
-5%
+126% +83% +90% +257%
Table 2: Effect of red kapok flower polysaccharides (RKFP) on the product of lactic acid by L. acidophilus
vulvar area for a soothing effect. Lactobacillus were determined by qPCR from the swab. The grouping of the 4 groups having applied the active ingredient shows a prebiotic effect on Lactobacilli L. crispatus (+31%) and L. jensenii (+29%) but not on
L.iners, a lactobacillus more likely to promote dysbiosis conditions of the vaginal flor (Figure 3). The total flora does not vary significantly from a physiological point of view. The active ingredient respects the vulval flora on the whole (Figure 4).
+29% -27% +31%
7.0 6.0 5.0 4.0 3.0 2.0 1.0 0.0
L.crispatus
L.jensenii
L.iners
Figure 3: illustration of the results of the presence of each strain of lactobacillus for groups 1 to 4: L. iners, crispatus and jensenii
PERSONAL CARE March 2023
Figure 4: illustration of the results of the quantification of total flora expressed in Log10 (copies/mL) lactobacillus for groups 1 to 4
www.personalcaremagazine.com 5.8 6.1 Development
Clinical scoring by a gynecologist A clinical scoring was performed by a gynecologist on four parameters evaluated on a scale 0 to 9 at D0 and D28: erythema, dryness, fissure, and irritation. The grouping of the four groups having applied the active ingredient shows a significant improvement of all the clinical scores, indicating the effectiveness of the active ingredient. Red kapok flower polysaccharides reduced
discomfort sensations (erythema -75%**, irritation -78%** and fissure -90%**) and moisturizes women’s intimate area (dryness -74%**) (Figure 5a). For the post-menopausal groups, we
observed a significant improvement in dryness (-80%**) and overall irritation (-92%**) for the active group, the control group expressing a borderline-significant improvement in dryness and a significant improvement in overall irritation, but lower than the active group. The comparison between the 2 groups shows
a borderline-significant difference in favour of the active group in terms of dryness (Figure 5b). The active ingredient improves the overall clinical signs evaluated.
Auto-scoring An auto-scoring was performed by the volunteers on themselves with three parameters evaluated on a scale 0 to 9 at D0 and D28: burning sensation, pruritus (itching sensation) and
D0 ■ D28 ■
Total 16SRNA Log10 (copies/mL) quantified
5000x % subject with detected strain
5000x
Concentration Log10 (copies/mL)
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