A placebo-controlled, double-blind clinical trial to evaluate the efficacy of Imedeen(®) Time Perfection(®) for improving the appearance of photodamaged skin

Thomas J Stephens, Monya L Sigler, James H Herndon Jr, Lisa Dispensa, Anne Le Moigne, Thomas J Stephens, Monya L Sigler, James H Herndon Jr, Lisa Dispensa, Anne Le Moigne

Abstract

Objective: To assess the efficacy of Imedeen Time Perfection for improving the appearance and condition of photoaged skin in healthy women.

Methods: This randomized, double-blind, placebo-controlled clinical trial enrolled healthy women, 35-60 years of age, with Fitzpatrick I-III and Glogau II-III skin types and mild-to-moderate facial fine lines/wrinkles. The eligible subjects were randomized to receive two tablets daily of either Imedeen Time Perfection (Imedeen) or a matching placebo for 12 weeks. Efficacy assessments included investigator rating of 16 photoaging parameters (ie, global facial appearance and 15 individual facial parameters and the average of all parameters), instrumentation (ie, ultrasound dermal density, moisture level of the stratum corneum, transepidermal water loss, cutometry), and subjects' self-assessment. Differences in the mean change from baseline to week 12 values on these outcomes were compared between Imedeen and placebo using analysis of variance or a paired t-test.

Results: Seventy-four subjects with primarily Fitzpatrick skin type III (78%-79%) and Glogau type III (53%-58%) completed the study (Imedeen: n=36; placebo: n=38). The mean difference in change from baseline to week 12 for global facial assessment significantly favored Imedeen over placebo (-0.52; P=0.0017). Additionally, the mean differences in the average of all facial photoaging parameters (-0.29), mottled hyperpigmentation (-0.25), tactile laxity (-0.24), dullness (-0.47), and tactile roughness (-0.62) significantly favored Imedeen over placebo (P≤0.05). Significantly greater increases in ultrasound dermal density (+11% vs +1%; P≤0.05) and stratum corneum moisturization (+30% vs +6%; P≤0.05) were also observed for Imedeen than for placebo. There were no significant differences on other instrumental outcomes.

Conclusion: The results of this study suggest that Imedeen Time Perfection can positively affect the appearance of photoaged skin, moisturization, and skin density over 12 weeks of treatment.

Keywords: dietary supplement; marine complex; photoaging.

Figures

Figure 1
Figure 1
Week 12 mean change from baseline values for the average of all clinical grading parameters and the global assessment. Abbreviation: SD, standard deviation.
Figure 2
Figure 2
Week 12 mean change from baseline values for skin color and texture (A), wrinkles and sagging (B), and undereye circles and bags, pore size, telangiectasia, and blotchiness (C). Abbreviation: SD, standard deviation.
Figure 2
Figure 2
Week 12 mean change from baseline values for skin color and texture (A), wrinkles and sagging (B), and undereye circles and bags, pore size, telangiectasia, and blotchiness (C). Abbreviation: SD, standard deviation.

References

    1. Fisher GJ, Wang ZQ, Datta SC, Varani J, Kang S, Voorhees JJ. Pathophysiology of premature skin aging induced by ultraviolet light. N Engl J Med. 1997;337(20):1419–1428.
    1. Kohl E, Steinbauer J, Landthaler M, Szeimies RM. Skin ageing. J Eur Acad Dermatol Venereol. 2011;25(8):873–884.
    1. Draelos ZD. Cosmetics, diet, and the future. Dermatol Ther. 2012;25(3):267–272.
    1. Fuchs J, Kern H. Modulation of UV-light-induced skin inflammation by D-alpha-tocopherol and L-ascorbic acid: a clinical study using solar simulated radiation. Free Radic Biol Med. 1998;25(9):1006–1012.
    1. Leccia MT, Richard MJ, Beani JC, et al. Protective effect of selenium and zinc on UV-A damage in human skin fibroblasts. Photochem Photobiol. 1993;58(4):548–553.
    1. Boyera N, Galey I, Bernard BA. Effect of vitamin C and its derivatives on collagen synthesis and cross-linking by normal human fibroblasts. Int J Cosmet Sci. 1998;20(3):151–158.
    1. Traber MG, Stevens JF. Vitamins C and E: beneficial effects from a mechanistic perspective. Free Radic Biol Med. 2011;51(5):1000–1013.
    1. Aust O, Stahl W, Sies H, Tronnier H, Heinrich U. Supplementation with tomato-based products increase lycopene, phytofluene, and phytoene levels in human serum and protects against UV-light-induced erythema. Int J Vitam Nutr Res. 2005;75(1):54–60.
    1. De Spirt S, Sies H, Tronnier H, Heinrich U. An encapsulated fruit and vegetable juice concentrate increases skin microcirculation in healthy women. Skin Pharmacol Physiol. 2012;25(1):2–8.
    1. Janjua R, Munoz C, Gorell E, et al. A two-year, double-blind, randomized placebo-controlled trial of oral green tea polyphenols on the long-term clinical and histologic appearance of photoaging skin. Dermatol Surg. 2009;35(7):1057–1065.
    1. Kopcke W, Krutmann J. Protection from sunburn with beta-carotene – a meta-analysis. Photochem Photobiol. 2008;84(2):284–288.
    1. Nichols JA, Katiyar SK. Skin photoprotection by natural polyphenols: anti-inflammatory, antioxidant and DNA repair mechanisms. Arch Dermatol Res. 2010;302(2):71–83.
    1. Rietveld M, Janson D, Siamari R, Vicanova J, Andersen MT, El Ghalbzouri A. Marine-derived nutrient improves epidermal and dermal structure and prolongs the life span of reconstructed human skin equivalents. J Cosmet Dermatol. 2012;11(3):213–222.
    1. Costa A, Pegas Pereira ES, Favaro R, et al. Treating cutaneous photoaging in women with an oral supplement based on marine protein, concentrated acerola, grape seed extract and tomato extract, for 360 days. Surg Cosmet Dermatol. 2011;3(4):302–311.
    1. Costa A, Lindmark L, Arruda LH, et al. Clinical, biometric and ultrasound assessment of the effects of daily use of a nutraceutical composed of lycopene, acerola extract, grape seed extract and Biomarine Complex in photoaged human skin. An Bras Dermatol. 2012;87(1):52–61.
    1. Vicanova J, Bouez C, Lacroix S, Lindmark L, Damour O. Epidermal and dermal characteristics in skin equivalent after systemic and topical application of skin care ingredients. Ann N Y Acad Sci. 2006;1067:337–342.
    1. Heule F. The improvement of the consequences of cutaneous aging: a double-blind analysis of the effect of the marine protein formula IMEDEEN [abstract] J Eur Acad Dermatol Venereol. 1994;3(2):224.
    1. Skovgaard GR, Jensen AS, Sigler ML. Effect of a novel dietary supplement on skin aging in post-menopausal women. Eur J Clin Nutr. 2006;60(10):1201–1206.
    1. Beguin A. A novel micronutrient supplement in skin aging: a randomized placebo-controlled double-blind study. J Cosmet Dermatol. 2005;4(4):277–284.
    1. Fanian F, Mac-Mary S, Jeudy A, et al. Efficacy of micronutrient supplementation on skin aging and seasonal variation: a randomized, placebo-controlled, double-blind study. Clin Interv Aging. 2013;8:1527–1537.
    1. Udompataikul M, Sripiroj P, Palungwachira P. An oral nutraceutical containing antioxidants, minerals and glycosaminoglycans improves skin roughness and fine wrinkles. Int J Cosmet Sci. 2009;31(6):427–435.
    1. Goldsberry A, Hanke CW, Hanke KE. VISIA system: a possible tool in the cosmetic practice. J Drugs Dermatol. 2014;13(11):1312–1314.

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