Safety and Photoprotective Efficacy of a Sunscreen System Based on Grape Pomace (Vitis vinifera L.) Phenolics from Winemaking
Abstract
:1. Introduction
2. Materials and Methods
2.1. Chemicals
2.2. Crude Extract
2.3. Design of Experiment (DoE)
2.3.1. Formulations
2.3.2. Antioxidant Activity
2.3.3. Sun Protection Factor (In Vitro SPF) and Photostability
2.4. Clinical Trials
2.4.1. Subjects
2.4.2. Primary and Cumulative Cutaneous Irritability and Sensitization Tests
- Induction (1st to 3rd week): hypoallergenic adhesive tape (Finn Chambers, Epitest, Rannankoukku, Tuusula, Finland) containing the test samples (E and F) and distilled water as negative control was applied at random sites on the back of each volunteer. If any volunteer showed signs at this negative control site, they would have been excluded from the research. Clinical signs and discomfort were reported to the dermatologist and the samples were reapplied in the same area;
- Rest (4th to 5th week): no product application;
2.4.3. Phototoxicity and Photosensitization Test
- Induction (1st to 2nd week): hypoallergenic adhesive tape (Finn Chambers, Epitest) containing the samples (E and F) and distilled water as negative control was randomly applied on the back skin of the subject and maintained for 48 h, after which the adhesive tape was removed from the skin and the areas were exposed to UVA and UVB radiation for 6 min 4 s. Clinical signs were reported to the dermatologist and products were reapplied in the same area;
- Rest (3rd to 4th week): no sample was applied;
- Challenge (5th week): samples were in contact with the skin for 48 h, after which the adhesive tape was removed from the skin and the areas were re-irradiated.
2.4.4. Clinical Photoprotective Effectiveness
2.4.5. UVA Protection Factor (UVA-PF)
2.5. Statistical Analysis
3. Results
3.1. Design of Experiment (DoE)
3.1.1. Formulations
3.1.2. Antioxidant Activity
3.1.3. Sun Protection Factor (In Vitro SPF) and Photostability
3.1.4. Critical Wavelength
3.1.5. UVA Transmittance
3.1.6. UVB Transmittance
3.1.7. UVA/UVB Ratio
3.2. Clinical Trials
3.2.1. Primary, Accumulated Dermal Irritability Test, and Sensitization
3.2.2. Phototoxicity and Photosensitization Test
3.2.3. Photoprotective Effectiveness
3.2.4. UVA Protection Factor (UVA-PF)
4. Discussion
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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INCI 1. | Composition% (w/w) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
A | B | C | D | E | F | G | H | I | J | K | |
Aqueous phase | |||||||||||
Ammonium acryloyldimethyltaurate/VP copolymer, trilaureth-4 phosphate, rapeseed oil sorbitol esters, mineral oil and isopropyl palmitate | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 |
Ammonium acryloyldimethyltaurate vinylpyrrolidone | 0.50 | 0.50 | 0.50 | 0.50 | 0.50 | 0.50 | 0.50 | 0.50 | 0.50 | 0.50 | 0.50 |
Propylene glycol | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 |
Ethyl alcohol | 2.50 | 2.50 | 2.50 | 2.50 | 2.50 | 2.50 | 2.50 | 2.50 | 2.50 | 2.50 | 2.50 |
Disodium EDTA | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 |
Grape pomace extract | 1.46 | 8.54 | 1.46 | 8.54 | 0.00 | 10.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 |
Water purified q.s. | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 |
Oil phase | |||||||||||
Butylmethoxydibenzoyl methane 2 | 0.73 | 0.73 | 4.27 | 4.27 | 2.50 | 2.50 | 0.00 | 5.00 | 2.50 | 2.50 | 2.50 |
Ethylhexyl methoxycinnamate 3 | 1.46 | 1.46 | 8.54 | 8.54 | 5.00 | 5.00 | 0.00 | 10.00 | 5.00 | 5.00 | 5.00 |
Ethylhexyl dimethyl PABA 3 | 1.17 | 1.17 | 6.83 | 6.83 | 4.00 | 4.00 | 0.00 | 8.00 | 4.00 | 4.00 | 4.00 |
Butyl hydroxy toluene | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 |
Mixture of phenoxyethanol and parabens others 4 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 |
Source | Y1 | Y2 | Y3 | Y4 | Y5 | Y6 | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Df | SS | P | Df | SS | P | Df | SS | P | Df | SS | P | Df | SS | P | Df | SS | P | |
Regression | 6 | 10.26 | 0.000 | 4 | 599.9 | 0.002 | 6 | 6150 | 0.000 | 6 | 11710 | 0.000 | 7 | 8358 | 0.000 | 3 | 0.756 | 0.000 |
Linear | ||||||||||||||||||
X1 | 1 | 0.89 | 0.000 | 1 | 36.7 | 0.021 | 1 | 3016 | 0.000 | 1 | 1645 | 0.000 | 1 | 1665 | 0.000 | 1 | 0.171 | 0.000 |
X2 | 1 | 0.32 | 0.005 | 1 | 65.2 | 0.010 | 1 | 15 | 0.174 | 1 | 380 | 0.009 | 1 | 209 | 0.014 | 1 | 0.050 | 0.000 |
X3 | 1 | 0.90 | 0.000 | 1 | 105 | 0.002 | 1 | 541 | 0.003 | 1 | 484 | 0.001 | ||||||
Quadratic | ||||||||||||||||||
X1 × X1 | 1 | 0.39 | 0.002 | 1 | 2146 | 0.000 | 1 | 753 | 0.001 | 1 | 942 | 0.000 | 1 | 0.085 | 0.000 | |||
X2 × X2 | 1 | 0.07 | 0.133 | 1 | 28.2 | 0.030 | 1 | 183 | 0.057 | 1 | 127 | 0.048 | ||||||
X3 × X3 | 1 | 0.17 | 0.029 | 1 | 103 | 0.144 | 1 | 82 | 0.106 | |||||||||
Interaction | ||||||||||||||||||
X1 × X2 | 1 | 8.2 | 0.128 | 1 | 39 | 0.035 | ||||||||||||
X1 × X3 | ||||||||||||||||||
X2 × X3 | 1 | 34 | 0.048 | 1 | 98 | 0.079 | ||||||||||||
Error | 17 | 0.51 | 3 | 5.6 | 17 | 128 | 17 | 44 | 16 | 444 | 20 | 0.043 | ||||||
Total | 23 | 10.77 | 7 | 605.5 | 23 | 6278 | 23 | 12456 | 23 | 8802 | 23 | 0.799 |
Regression Equation | 1 R2 | 2 R2adj | 3 R2pred |
---|---|---|---|
ln(Y1) = 0.341 + 0.2817 × X1 + 0.1258 × X2 − 0.857 × X3 − 0.01409 × X1 × X1 − 0.00579 × X2 × X2 + 0.1795 × X3 × X3 | 0.9522 | 0.9354 | 0.8849 |
Y2 = 24.35 − 1.017 × X1 + 3.631 × X2 − 0.1831 × X2 × X2 + 0.0861 × X1 × X2 | 0.9907 | 0.9783 | 0.8295 |
Y3 = 328.35 + 16.112 × X1 + 0.722 × X2 − 4.91 × X3 − 0.9844 × X1 × X1 − 0.1092 × X1 × X2 + 0.477 × X2 × X3 | 0.9796 | 0.9723 | 0.9361 |
Y4 = 96.51 − 12.11 × X1 − 4.31 × X2 + 20.96 × X3 + 0.617 × X1 × X1 + 0.285 × X2 × X2 − 4.39 × X3 × X3 | 0.9401 | 0.9190 | 0.8581 |
Y5 = 68.08 − 12.19 × X1 − 3.41 × X2 + 21.78 × X3 + 0.691 × X1 × X1 + 0.238 × X2 × X2 − 3.91 × X3 × X3 − 0.808 × X2 × X3 | 0.9495 | 0.9275 | 0.8681 |
Y6 = 0.1409 + 0.1159 × X1 − 0.0559 × X3 − 0.006207 × X1 × X1 | 0.9459 | 0.9378 | 0.9082 |
Formulation | Concentration (% w/w) | Organoleptic Characteristics | ||||
---|---|---|---|---|---|---|
UV Filters 1 | GP 2 | Aspect 3 | Color | Odor 4 | pH | |
A | 3.37 | 1.46 | N | Light purple | C | 5.40 |
B | 3.37 | 8.54 | N | Wine | C | 5.46 |
E | 11.50 | 0.00 | N | Yellow | C | 5.40 |
F | 11.50 | 10.00 | SI | Dark purple | C | 5.49 |
G | 0.00 | 5.00 | N | Wine | C | 5.46 |
I | 11.50 | 5.00 | N | Purple | C | 5.51 |
J | 11.50 | 5.00 | N | Purple | C | 5.45 |
K | 11.50 | 5.00 | N | Purple | C | 3.38 |
Formulation | % AAO 1 | Trolox (µmol g−1) 2 |
---|---|---|
A | 26.88 ± 0.02 | 306.76 ± 0.02 |
B | 41.68 ± 0.01 | 545.53 ± 0.01 |
E | 12.20 ± 0.00 | 64.92 ± 0.00 |
F | 40.10 ± 0.00 | 519.92 ± 0.00 |
G | 36.99 ± 0.00 | 469.30 ± 0.00 |
I | 32.64 ± 0.00 | 398.22 ± 0.00 |
J | 30.79 ± 0.01 | 368.05 ± 0.01 |
K | 30.02 ± 0.01 | 355.59 ± 0.01 |
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Hübner, A.A.; Sarruf, F.D.; Oliveira, C.A.; Neto, A.V.; Fischer, D.C.H.; Kato, E.T.M.; Lourenço, F.R.; Baby, A.R.; Bacchi, E.M. Safety and Photoprotective Efficacy of a Sunscreen System Based on Grape Pomace (Vitis vinifera L.) Phenolics from Winemaking. Pharmaceutics 2020, 12, 1148. https://doi.org/10.3390/pharmaceutics12121148
Hübner AA, Sarruf FD, Oliveira CA, Neto AV, Fischer DCH, Kato ETM, Lourenço FR, Baby AR, Bacchi EM. Safety and Photoprotective Efficacy of a Sunscreen System Based on Grape Pomace (Vitis vinifera L.) Phenolics from Winemaking. Pharmaceutics. 2020; 12(12):1148. https://doi.org/10.3390/pharmaceutics12121148
Chicago/Turabian StyleHübner, Alexandra A., Fernanda D. Sarruf, Camila A. Oliveira, Alberto V. Neto, Dominique C. H. Fischer, Edna T. M. Kato, Felipe R. Lourenço, André Rolim Baby, and Elfriede M. Bacchi. 2020. "Safety and Photoprotective Efficacy of a Sunscreen System Based on Grape Pomace (Vitis vinifera L.) Phenolics from Winemaking" Pharmaceutics 12, no. 12: 1148. https://doi.org/10.3390/pharmaceutics12121148