Efficacy Evaluation of a Cosmetic Product for the Periocular Area in Caucasian Women Aged Over 40 Years Old

Figures & data

Figure 1 (A) Skin elasticity measurement process. (B) R0 (skin distensibility) represents the passive behavior of the skin to force (ie, gravity). Conceptually R0 parameter is correlated to skin firmness. (C) R2 (Ua/Uf, gross elasticity or overall elasticity) represents the ability of the skin to return to its basal state.

Table 1 Clinical Scoring System

	Classification at D0*	Score	Classification at D28**	Score
Skin wrinkledness	No wrinkle. No visible wrinkles;	0	No variation	1
	Continuous skin line.		Mild improvement	2
	Very shallow yet visible wrinkles.	0.5	Moderate improvement	3
	Fine wrinkle. Visible wrinkles and slight	1.0	Remarkable improvement	4
	Indentation.
	Visible wrinkles and clear indentation.	1.5
	Moderate wrinkles. Clearly visible wrinkles.	2
	Prominent and visible wrinkles.	2.5
	Deep wrinkles. Deep wrinkles and furrows.	3
Bags under the eye	Under eye bags are very swollen		No variation	1
	Under eye bags are slightly swollen		Mild improvement	2
	Under eye bags are not swollen		Moderate improvement	3
			Remarkable improvement	4
Dark circles	Dark circles are very dark		No variation	1
	Dark circles are slightly dark		Mild improvement	2
	The palpebral skin color is normal		Moderate improvement	3
			Remarkable improvement	4

Note: *Basal visit, **Follow-up visit after 28 days of product use.

Table 2 Subjects’ Baseline Demographic and Clinical Characteristics

Baseline Characteristic	Value	Units
Sex	40 (100%)	N (%)
Age	54.9 ± 1.0	Years
Subjects with bags under the eye and wrinkles	20 (50%)	n (%)
Subjects with dark circles and wrinkles	20 (50%)	n (%)
Bags under the eye volume	19.51 ± 1.48	mm^3
Dark circles color
Red component (a*)	14.749 ± 0.739	Arbitrary units
Blue component (b*)	−21.158 ± 0.748	Arbitrary units
Wrinkle depth	344.6 ± 25.9	mm
Skin smoothness (Sa)	38.2 ± 1.6	mm
Skin moisturization	59.4 ± 1.3	Corneometric units
Skin elasticity
R0 (skin distensibility)	0.2916 ± 0.091	mm
R2 (overall elasticity)	0.4957 ± 0.0146	%
Skin radiance	11.4 ± 0.6	Arbitrary units

Figure 2 (A) Bags under the eye volume results. (B) Dark circles color results (a*, red component). (C) Dark circles color results (b*, blue component). Data are average (± standard error). The statistical analysis (D28 vs D0) is reported above the bar as follows: ** p<0.01. au arbitrary units. D0 baseline. D28 follow-up visit after 28 days of product use.

Figure 3 (A) Periocular wrinkles (standard general white lighting). (B) Bags under the eye volume results (standard general white lighting). (C) Dark circles color (cross-polarized filter).

Table 3 Secondary Endpoint Results

Parameter	D0	D28	Units	% Variation
Wrinkle depth	344.6 ± 25.9	284.7 ± 20.1 **	mm	−15.8%
Skin smoothness, Sa	38.2 ± 1.6	35.7 ± 1.7 *	mm	−6.3%
Skin moisturization	59.4 ± 1.3	66.1 ± 1.1 ***	cu	+11.7%
Skin elasticity
R0 (skin distensibility)	0.2916 ± 0.091	0.2661 ± 0.0100 ***	mm	−8.9%
R2 (overall elasticity)	0.4957 ± 0.0146	0.5466 ± 0.0165 ***	%	+10.4%
Skin radiance	11.4 ± 0.6	13.0 ± 0.3 ***	au	+16.3%

Notes: Data are average (± standard error). The statistical analysis (D28 vs D0) is reported as follows: * p<0.05, ** p<0.01, and ***p<0.005. D0 baseline. D28 follow-up visit after 28 days of product use. au arbitrary units. cu corneometric units.

Table 4 Self-Assessment Questionnaire Output. Data are the Percentage of Subjects Giving a Particular Answer

No.	Item	Completely Agree	Agree	Disagree	Completely Disagree	Positive Answers
01	The product reduces the bags under the eye puffiness*	15%	75%	10%	0%	90%
02	The product reduces dark circles color**	25%	70%	5%	0%	95%
03	The product reduces fine lines/wrinkles visibility	20%	70%	10%	0%	90%
04	The product improves skin brightness	35%	65%	0%	0%	100%
05	The product improves skin firmness	40%	58%	3%	0%	98%
06	The product improves skin moisturization	35%	65%	0%	0%	100%
07	The product has a smoothing effect	35%	60%	5%	0%	95%
08	The product reduces signs of fatigue	20%	73%	8%	0%	93%
09	The product has a pleasant texture	63%	35%	3%	0%	98%
10	The product is quickly absorbed	48%	50%	3%	0%	98%
11	The product is easy to apply	63%	38%	0%	0%	100%
No.	Item	Yes	No			Positive answers
12	Are you satisfied with the product?	100%	0%			100%
13	Would you buy the product?	98%	3%			98%
14	Is the product well tolerated?	100%	0%			100%

Notes: * The question was asked only to subjects showing bags under the eyes (n = 20). ** The question was asked only to subjects showing dark circles (n = 20).