Assessment of clinical effects and safety of an oral supplement based on marine protein, vitamin C, grape seed extract, zinc, and tomato extract in the improvement of visible signs of skin aging in men

Figures & data

Table 1 Clinical effects according to medical assessment

Parameter	Day 60		Day 90		Day 120		Day 150		Day 180		Day 210		P-value in relation to day 60
	N	%	N	%	N	%	N	%	N	%	N	%	Day 90	Day 120	Day 150	Day 180	Day 210
Wrinkles	20	49.00	33	80.00	27	66.00	22	54.00	13	32.00	23	56.00	0.003	0.108	0.670	0.108	0.549
Fine lines	20	49.00	33	80.00	30	73.00	21	51.00	13	32.00	23	56.00	0.003	0.025	0.835	0.108	0.549
Solar melanosis	16	39.00	31	76.00	14	34.00	9	22.00	5	12.00	13	32.00	0.001	0.655	0.108	0.005	0.467
Other hyperchromias	18	44.00	29	71.00	16	39.00	11	27.00	6	15.00	13	32.00	0.016	0.655	0.071	0.003	0.251
Erythema	15	37.00	24	59.00	9	22.00	7	17.00	9	22.00	22	54.00	0.071	0.532	0.317	0.513	0.018
Hydration	31	76.00	41	100.00	40	98.00	39	95.00	41	100.00	40	98.00	–	0.003	0.011	–	0.007
Radiance	31	76.00	41	100.00	38	93.00	38	93.00	41	100.00	40	98.00	–	0.020	0.020	–	0.007
Sebum	17	41.00	39	95.00	31	76.00	23	56.00	32	78.00	23	56.00	<0.001	0.002	0.134	0.003	0.109
Smoothness	31	76.00	41	100.00	39	95.00	39	95.00	40	98.00	41	100.00	–	0.011	0.021	0.007	–
Overall appearance	34	83.00	41	100.00	40	98.00	38	93.00	41	100.00	40	98.00	–	0.035	0.132	–	0.035

Table 2 Clinical effects according to subjects’ self-assessment

Parameter	Day 60		Day 90		Day 120		Day 150		Day 180		Day 210		P-value in relation to day 60
	N	%	N	%	N	%	N	%	N	%	N	%	Day 90	Day 120	Day 150	Day 180	Day 210
Wrinkles	19	46.00	32	78.00	32	78.00	28	68.00	29	71.00	34	83.00	0.003	<0.001	0.02	0.018	<0.001
Fine lines	18	44.00	32	78.00	31	76.00	27	66.00	29	71.00	35	85.00	0.002	<0.001	0.013	0.008	<0.001
Solar melanosis	16	39.00	25	61.00	23	56.00	21	51.00	22	54.00	31	76.00	0.039	0.071	0.414	0.134	0.001
Other hyperchromias	14	34.00	24	59.00	22	54.00	21	51.00	22	54.00	32	78.00	0.033	0.046	0.221	0.059	<0.001
Erythema	9	22.00	20	49.00	16	39.00	14	34.00	11	27.00	29	71.00	0.008	0.035	0.251	0.564	<0.001
Hydration	26	63.00	39	95.00	38	93.00	38	93.00	33	80.00	39	95.00	0.001	0.001	0.001	0.090	<0.001
Radiance	25	61.00	37	90.00	35	85.00	38	93.00	32	78.00	39	95.00	0.001	0.008	<0.001	0.071	<0.001
Sebum	22	54.00	28	68.00	29	71.00	30	73.00	21	51.00	32	78.00	0.637	0.201	0.046	0.841	0.012
Smoothness	26	63.00	36	88.00	34	83.00	37	90.00	37	90.00	37	90.00	0.012	0.046	0.002	0.002	0.002
Overall appearance	27	66.00	40	98.00	37	90.00	36	88.00	37	90.00	38	93.00	0.001	0.004	0.007	0.012	0.002

Table 3 Grading (arbitrary units) and percentile improvement in the objective clinical parameters according to the VISIAa system at day 210 in relation to day 30

	Day 30	Day 210	Improvement	% improvement	P-value
Spots
Grading	2,665	2,453	212	8	0.008
Percentile	47%	57%	10%	21	<0.001
Texture
Grading	2,403	2,090	313	34	0.017
Percentile	58%	69%	11%	19	0.001
Pores
Grading	2,334	1,896	438	23	0.001
Percentile	44%	65%	21%	48	<0.001
UV spots
Grading	1,057	599	458	76	<0.001
Brown spots
Grading	5,418	3,539	1,879	53	<0.001

Note:

a Canfield Imaging Systems, Fairfield, NJ, USA.

Abbreviation: UV, ultraviolet.

Table 4 Changes in facial skin hydration, facial skin pH, facial density, facial sebumetry, and sebumetry of inner side of arm (arm sebumetry) during the study

	Average	Median	Standard deviation	Minimum	Maximum	P-value
Face corneometry (hydration units)
Day 30	59.3	54.4	18.9	39.2	162.4	0.014
Day 210	67.6	63.0	21.0	34.4	113.4
Face pHmetry
Day 30	4.8	4.8	0.5	3.5	6.0	<0.001
Day 210	4.6	4.6	0.4	3.5	5.2
Ultrasound scan, face (arbitrary units)
Day 30	31.41	29	7.5	18	50	<0.001
Day 210	69.77	66	10.32	55	96
Face sebumetry (mg/cm^2)
Day 30	98.0	86.3	50.5	22.0	218.8	0.861
Day 210	100.9	85.7	54.1	18.0	254.0
Arm sebumetry (mg/cm^2)
Day 30	7.0	1.0	16.2	0.0	78.0	0.398
Day 210	7.1	2.0	13.0	0.0	71.0

Figure 1 Histological images showing collagen and elastic fibers of face and left arm before and after treatment.

Notes: (A) Collagen evidenced by Masson’s trichrome method. (B) Elastic fibers evidenced by Verhoeff method.
Abbreviation: D, day.

Figure 2 Histological exam showing collagen and elastic fibers of face and left arm before and after treatment.

Notes: (A) Collagen evidenced by Masson’s trichrome method. (B) Elastic fibers evidenced by Verhoeff method.
Abbreviation: D, day.

Figure 3 Collagen evidenced by ultrasound images before and after intervention.

Abbreviation: D, day.

Table 5 Evolution of collagen and elastic fibers of inner side of left arm long the study according to histological findings

Left arm biopsy	Average (%)	Median (%)	Standard deviation (%)	Minimum (%)	Maximum (%)	P-value
Collagen
Day 30	42.5	42.9	11.4	10.2	62.4	<0.001
Day 210	57.4	58.2	9.6	39.5	76.6
Elastic fibers
Day 30	14.6	12.8	7.9	4.4	33.7	0.004
Day 210	19.8	18.1	9.3	7.4	51.8

Table 6 Evolution of facial collagen and elastic fibers during the study according to histological findings

Face biopsy	Average (%)	Median (%)	Standard deviation (%)	Minimum (%)	Maximum (%)	P-value
Collagen
Day 30	43.0	42.5	9.9	25.2	66.0		<0.001
Day 210	57.4	57.8	9.7	31.2	89.6
Elastic fibers
Day 30	19.7	16.6	13.3	4.6	58.8		<0.001
Day 210	31.2	26.9	16.0	9.3	64.8