FORMULATING FOR MILDNESS
Preventive effect on the appearance of the erythema The figures represent the pair-to-pair comparisons between the active ingredient, placebo and untreated area on the intensity of the erythema 20 minutes after application of Methyl-Nicotinate measured by TiVi. The parameter in the ordinate represents the intensity of the blood flow (concentration in blood cells). The exact numeric values are in the tables below. The results demonstrate that the active ingredient significantly reduces the intensity of the erythema created compared to the untreated area. The intensity of the erythema on the placebo area does not differ from the treated area. The intensity of the erythema on the active ingredient area is significantly lower compared to the placebo. Figure 11 shows the evolution of the blood
flow values over time. The measures performed by TiVi show that the active ingredient has an anti-inflammatory effect.
Evaluation of colour by spectrocolorimetry The colour of the skin is evaluated by spectrocolorimetry in the L*a*b* space where: ■ L* corresponds to the clarity of the skin (from darkest to lightest) ■ a* corresponds to the channel going from green to red ■ b* corresponds to the channel going from blue to yellow In the case of a study of an anti-inflammatory
effect, we examine: ■ The evolution of the redness a*, a decrease in its value indicates an anti-inflammatory effect.
Preventive effect on the appearance of the erythema ■ On redness a* Figure 12 represents the pair-to-pair comparisons between the active ingredient, placebo and untreated area on the intensity of the erythema 20 minutes after application of Methyl-Nicotinate measured by spectrocolorimetry on parameter a*. The parameter in the ordinate represents the redness of the skin. The exact numeric values are in the tables below. The results show that the active ingredient
area has an erythema intensity that is lower than the untreated area. The area treated with placebo shows no difference with the untreated area. No difference between the active ingredient
ERYTHEMA INTENSITY AT 20MIN-a* t20’-t0
4.4 4.2 4.0 3.8 3.6 3.4
Non treated ns -11.5%* vs non-treated skin BLOOD FLOW MEASURED BY TiVi T0min T20min T50min
33
Non-treated
Placebo
Active ingredient 3%
Figure 11: Evolution of the blood flow over time.
and placebo is only observed, however, there is trend in favour the active ingredient.
Evaluation of the soothing and moisturising efficacy of the active ingredient on sensitive skin versus placebo Trial design: ■ Double blind study ■ Comparative active ingredient vs placebo, randomised study in half of face
Population: Concerning the measure of hydration, transepidermal water loss, colour and questionnaire, 36 healthy female subjects with Caucasian type (Phototype I to IV), sensitive skin on face (the skin of the subject must react to at least 2 of 3 of the following stress factors: environmental, chemical or mechanical) and aged over 18 years (mean age 51±3) were included in the analysis.
TEWL EVOLUTION -9.2% vs placebo Placebo Active Ingredient 3%
Figure 12: Active ingredient/Placebo/Untreated area comparisons. NS: non-significant difference *: p<0.05
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20 18 16 14 12 10 8 6 4 2 0
Concerning the biochemical tests, 10 subjects were included in the analysis.
Methods of use and conduct of the study: At D0: ■ Verification of inclusion and non-inclusion criteria ■ Acclimatisation for 30 minutes ■ Definition measurement areas on each half of the face ■ Instrumental measures and biological samples Between D0 and D28: ■ Application of the active ingredient in a cream and placebo on half of the face 2 times daily (morning and evening) At D28: ■ Acclimatisation for 30 minutes ■ Instrumental measures and biological samples ■ Self-evaluation questionnaire
D28-D0 TEWL EVOLUTION
D0 ■ D28■
-15.6%*** -10.4%***
2 0
14.41 14.19 12.16 12.71
-2 -4 -6
Active Ingredient 3% Placebo Figure 13: Illustrations of the TEWL results obtained on D0 and D28. *: p<0.05 April 2021 PERSONAL CARE -4.3%*
-1.48 -2.25 Active Ingredient 3% Placebo
a* ( t20’-t0)
TEWLg/m2
/h
TEWLg/m2
/h
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