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      Safety and efficacy of a growth factor and cytokine-containing topical product in wound healing and incision scar management after upper eyelid blepharoplasty: a prospective split-face study

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          Abstract

          Purpose

          To evaluate the efficacy and safety of a topical product containing a mixture of growth factors and cytokines on the incision scar following upper eyelid blepharoplasty.

          Methods

          This is a prospective, single-blinded, and split-face study on patients who underwent bilateral upper eyelid blepharoplasty. Two weeks after surgery, one eye of each subject was randomized to receive Lumière Bio-Restorative Eye Cream on one eyelid incision for 12 weeks and no treatment on the other eyelid. Subjects returned at the postoperative weeks 6, 10, and 14. At each visit, patients and the investigator (who was blinded to the treated eyelid) evaluated the scar through specified questionnaires.

          Results

          A total of 20 subjects with a mean age of 66.3±9.2 years completed the study. Minor side effects were noted in three subjects. At all-time points, all subjects thought eyelids treated with Lumière had a better scar and overall appearance than fellow eyelids ( P<0.5); and 60% of patients strongly encouraged others to use the product. The investigator assessment of erythema and pigmentation revealed less erythema and pigmentation in treated eyes at the weeks 6 and 10, although the difference was statistically insignificant. Investigator assessment also revealed a better scar appearance at week 10 in treated eyes ( P=0.04). All evaluation parameters were similar in both eyes at the last visit.

          Conclusion

          Lumière eye cream shows an excellent safety profile and minimal effects on features of the incision scar following upper lid blepharoplasty. It may hasten the wound healing process considering the higher outcomes at the first weeks of application.

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          Most cited references14

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          Regulation of wound healing by growth factors and cytokines.

          Cutaneous wound healing is a complex process involving blood clotting, inflammation, new tissue formation, and finally tissue remodeling. It is well described at the histological level, but the genes that regulate skin repair have only partially been identified. Many experimental and clinical studies have demonstrated varied, but in most cases beneficial, effects of exogenous growth factors on the healing process. However, the roles played by endogenous growth factors have remained largely unclear. Initial approaches at addressing this question focused on the expression analysis of various growth factors, cytokines, and their receptors in different wound models, with first functional data being obtained by applying neutralizing antibodies to wounds. During the past few years, the availability of genetically modified mice has allowed elucidation of the function of various genes in the healing process, and these studies have shed light onto the role of growth factors, cytokines, and their downstream effectors in wound repair. This review summarizes the results of expression studies that have been performed in rodents, pigs, and humans to localize growth factors and their receptors in skin wounds. Most importantly, we also report on genetic studies addressing the functions of endogenous growth factors in the wound repair process.
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            The 500 Dalton rule for the skin penetration of chemical compounds and drugs.

            Human skin has unique properties of which functioning as a physicochemical barrier is one of the most apparent. The human integument is able to resist the penetration of many molecules. However, especially smaller molecules can surpass transcutaneously. They are able to go by the corneal layer, which is thought to form the main deterrent. We argue that the molecular weight (MW) of a compound must be under 500 Dalton to allow skin absorption. Larger molecules cannot pass the corneal layer. Arguments for this "500 Dalton rule" are; 1) virtually all common contact allergens are under 500 Dalton, larger molecules are not known as contact sensitizers. They cannot penetrate and thus cannot act as allergens in man; 2) the most commonly used pharmacological agents applied in topical dermatotherapy are all under 500 Dalton; 3) all known topical drugs used in transdermal drug-delivery systems are under 500 Dalton. In addition, clinical experience with topical agents such as cyclosporine, tacrolimus and ascomycins gives further arguments for the reality of the 500 Dalton rule. For pharmaceutical development purposes, it seems logical to restrict the development of new innovative compounds to a MW of under 500 Dalton, when topical dermatological therapy or percutaneous systemic therapy or vaccination is the objective.
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              Reversal of photodamage with topical growth factors: a pilot study.

              Interest in the reversal of facial photodamage has increased significantly among patients and physicians in the past decade. Though surgical procedures may be very effective, the associated healing time and potential risks have spurred the development of non-surgical treatments. There has also been an increasing depth of knowledge regarding wound healing and its control by growth factors as well as its modulation by the topical application of growth factors. Bioengineered tissue cultures have resulted in the ability to collect naturally occurring human growth factors in their tissue concentrations. The objective of this study is to determine if the twice daily application of a combination of multiple growth factors to photodamaged facial skin results in any evidence of improvement after 60 days. Fourteen patients applied a gel containing a mixture of eight different growth factors (Nouricel-MD) to photodamaged facial skin twice daily. Prior to the study and at days there were clinical evaluations of photodamage (Fitzpatrick scale), 3 mm punch biopsies and optical profilometry. Patient questionnaires were answered at 60 days. Eleven of 14 patients showed clinical improvement in at least one facial area. The peri-orbital region showed a statistically significant improvement (p = 0.0003). Optical profilometry showed a statistically significant reduction in Ra measurement (p=0.0075) and shadowing (p=0.02), both indicating a decrease in the depth and number of textural irregularities or fine lines. Biopsies revealed new collagen formation in the Grenz zone (37% increase in thickness) and thickening of the epidermis by 27%. Eight of 14 patients felt their wrinkles were improved, while 12 of 14 felt their skin texture was improved. The application of a mixture of topical growth factors may stimulate the repair of facial photodamage resulting in new collagen formation, epidermal thickening and the clinical appearance of smoother skin with less visible wrinkling.
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                Author and article information

                Journal
                Clin Ophthalmol
                Clin Ophthalmol
                Clinical Ophthalmology
                Clinical Ophthalmology (Auckland, N.Z.)
                Dove Medical Press
                1177-5467
                1177-5483
                2016
                30 June 2016
                : 10
                : 1223-1228
                Affiliations
                [1 ]Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami Miller School of Medicine, Miami, FL, USA
                [2 ]Ophthalmic Research Center, Department of Ophthalmology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
                Author notes
                Correspondence: Wendy W Lee, Clinical Ophthalmology & Dermatology, Oculofacial Plastic & Reconstructive Surgery, Orbit and Oncology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, 900 NW 17th Street, Miami, FL 33136, USA, Tel +1 305 326 6434, Fax +1 305 326 6443, Email wlee@ 123456med.miami.edu
                [*]

                These authors contributed equally to this work

                Article
                opth-10-1223
                10.2147/OPTH.S109517
                4935006
                27418806
                01871d72-19b0-48ab-b599-3b324b19e470
                © 2016 Murdock et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                History
                Categories
                Original Research

                Ophthalmology & Optometry
                processed skin cell proteins,psp®,skin cream,eye cream,eyelid surgery,lumière

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