Cosmetic benefit of a biomimetic lamellar cream formulation on barrier function or the appearance of fine lines and wrinkles in randomized proof-of-concept clinical studies

S Nisbet, H Mahalingam, C F Gfeller, E Biggs, S Lucas, M Thompson, M R Cargill, D Moore, S Bielfeldt, S Nisbet, H Mahalingam, C F Gfeller, E Biggs, S Lucas, M Thompson, M R Cargill, D Moore, S Bielfeldt

Abstract

Objective: Two studies were designed to evaluate the potential cosmetic benefit of a biomimetic, niacinamide-containing moisturizing cream for the first time in humans.

Methods: In both studies, healthy women were randomized to use two treatments, one for the left side of the body and one for the right, from three options: the test cream, a positive control or no treatment (use of standard cleanser only). Treatments were applied twice daily for 4 weeks to the face and forearms (Study 1) or the face only (Study 2). Instrumental and clinical skin assessments were performed by trained technicians. Study 1 involved tape stripping and a 5-day no-treatment ('regression') period at the end of the 4 weeks. Independent lay graders were asked to grade the skin texture of subjects in Study 2 from high-resolution photographs.

Results: In Study 1 (n = 66), the test cream significantly decreased the transepidermal water loss (TEWL) values on the forearm, and in the cheek area of the face, relative to baseline and compared to no treatment, and increased skin Corneometer values. The improvements were partially retained during a subsequent 5-day period of no treatment. Increases in TEWL values on skin subjected to tape stripping were significantly lower after 4 weeks of using the test cream compared to no treatment. In Study 2 (n = 72 subjects with visible signs of ageing), there was a favourable trend in the change from baseline of a skin roughness parameter, Ra , for the test cream compared to no treatment. There were statistically significant improvements in the Fitzpatrick wrinkle score compared to no treatment, decreases in TEWL and increased Corneometer values and Cutometer values (R5 elasticity parameter). Grading of high-resolution images failed to detect the improvements in skin texture (defined as pores, smoothness and unevenness) for the test cream vs. no treatment. No treatment-related serious or severe adverse events were reported.

Conclusion: Twice daily application of the test cream over 4 weeks had beneficial effects on skin barrier function, moisturization, wrinkle dimensions and elasticity compared to no treatment. These studies provide proof-of-concept evidence and highlight the cosmetic benefit of the biomimetic lamellar cream formulation.

Study registration: NCT03216265, NCT03180645.

Keywords: emulsions; fine lines; formulation/stability; moisturizing lamellar cream; skin barrier; wrinkles.

© 2018 GSK. International Journal of Cosmetic Science published by John Wiley & Sons Ltd on behalf of Society of Cosmetic Scientists and the Société Française de Cosmétologie.

Figures

Figure 1
Figure 1
Subject flow. Screening and randomization of study subjects in (A) Study 1 and (B) Study 2. PP, per protocol; ITT, intent‐to‐treat.
Figure 2
Figure 2
TEWL measures – Study 1. Forearm (A) and face (B) TEWL measurements over time: ITT population in Study 1 (n = 65). Least squares mean changes from baseline. Baseline is measured prior to any study product application on Day 1. An increase in TEWL values shows damage to the skin barrier function. The P values shown are for the changes from baseline within a group. SE, standard error.
Figure 3
Figure 3
Corneometer values – Study 1. Forearm Corneometer values over time: ITT population in Study 1 (n = 65). (A) Raw means are presented. (B) Least squares mean changes from baseline. Baseline is measured prior to any study product application on Day 1. An increase in Corneometer value is indicative of a skin‐moisturizing effect. The P values shown are for the changes from baseline within a group. SD, standard deviation; SE, standard error.
Figure 4
Figure 4
Day 29 change from baseline in roughness parameter Ra – Study 2. Day 29 change from baseline in roughness parameter Ra on the periocular/crow's feet area in ITT Population of Study 2 (n = 70). A decrease in a roughness parameter corresponds to a decrease in the degree of wrinkles. SE, standard error.

References

    1. Harding, C.R. The stratum corneum: structure and function in health and disease. Dermatol. Ther. 17(Suppl 1), 6–15 (2004).
    1. Buraczewska, I. , Berne, B. , Lindberg, M. , Törmä, H. and Lodén, M. Changes in skin barrier function following long‐term treatment with moisturizers, a randomized controlled trial. Br. J. Dermatol. 156, 492–498 (2007).
    1. Cortázar, T.M. , Guzmán‐Alonso, M. , Novoa, H. and Riaño, M. Comparative study of temporary effect on the water content at different depths of the skin by hot and cold moisturizing formulations. Skin Res. Technol. 21, 265–271 (2015).
    1. van Zuuren, E.J. , Fedorowicz, Z. , Christensen, R. , Lavrijsen, A. and Arents, B.W.M. Emollients and moisturisers for eczema. Cochrane Database Syst. Rev. 2, CD012119 (2017).
    1. Farage, M.A. , Miller, K.W. , Elsner, P. and Maibach, H.I. Intrinsic and extrinsic factors in skin ageing: a review. Int. J. Cosmet. Sci. 30, 87–95 (2008).
    1. Naylor, E.C. , Watson, R.E.B. and Sherratt, M.J. Molecular aspects of skin ageing. Maturitas 69, 249–256 (2011).
    1. Ghersetich, I. , Lotti, T. , Campanile, G. , Grappone, C. and Dini, G. Hyaluronic acid in cutaneous intrinsic aging. Int. J. Dermatol. 33, 119–122 (1994).
    1. Wiest, L. and Kerscher, M. Native hyaluronic acid in dermatology–results of an expert meeting. J. Dtsch. Dermatol. Ges. 6, 176–180 (2008).
    1. Nisbet, S.J. and Dykes, P. Twelve‐hour skin hydration after a single application of a lamellar moisturizer. J. Cosmet. Sci. 66, 305–306 (2015).
    1. Eberlein, B. , Eicke, C. , Reinhardt, H.W. and Ring, J. Adjuvant treatment of atopic eczema: assessment of an emollient containing N‐palmitoylethanolamine (ATOPA study). J. Eur. Acad. Dermatol. Venereol. 22, 73–82 (2008).
    1. Szepietowski, J.C. , Szepietowski, T. and Reich, A. Efficacy and tolerance of the cream containing structured physiological lipids with endocannabinoids in the treatment of uremic pruritus: a preliminary study. Acta Dermatovenerol. Croat. 13, 97–103 (2005).
    1. Kim, J.M. , Kim, W.I. , Ko, H.C. , Kim, M.B. and Kim, B.S. Epidermal barrier function changes after ablative and non‐ablative fractional laser administration. J. Eur. Acad. Dermatol. Venereol. 31, e83–e85 (2017).
    1. Yuan, C. , Wang, X.M. , Guichard, A. , Tan, Y.M. , Qian, C.Y. , Yang, L.J. and Humbert, P. N‐palmitoylethanolamine and N‐acetylethanolamine are effective in asteatotic eczema: results of a randomized, double‐blind, controlled study in 60 patients. Clin. Interv. Aging 9, 1163–1169 (2014).
    1. Hartkamp, R. , Moore, T.C. , Iacovella, C.R. , Thompson, M.A. , Bulsara, P.A. , Moore, D.J. and McCabe, C. Composition dependence of water permeation across multicomponent gel‐phase bilayers. J. Phys. Chem. B. 122, 3113–3123 (2018).
    1. Bulsara, P.A. , Varlashkin, P. , Dickens, J. , Moore, D.J. , Rawlings, A.V. and Clarke, M.J. The rational design of biomimetic skin barrier lipid formulations using biophysical methods. Int. J. Cosmet. Sci. 39, 206–216 (2017).
    1. Wohlrab, J. and Kreft, D. Niacinamide ‐ mechanisms of action and its topical use in dermatology. Skin Pharmacol. Physiol. 27, 311–315 (2014).
    1. Tanno, O. , Ota, Y. , Kitamura, N. , Katsube, T. and Inoue, S. Nicotinamide increases biosynthesis of ceramides as well as other stratum corneum lipids to improve the epidermal permeability barrier. Br. J. Dermatol. 143, 524–531 (2000).
    1. Mohammed, D. , Crowther, J.M. , Matts, P.J. , Hadgraft, J. and Lane, M.E. Influence of niacinamide containing formulations on the molecular and biophysical properties of the stratum corneum. Int. J. Pharm. 441, 192–201 (2013).
    1. Gehring, W. Nicotinic acid/niacinamide and the skin. J. Cosmet. Dermatol. 3, 88–93 (2004).
    1. Fitzpatrick, R.E. , Goldman, M.P. , Satur, N.M. and Tope, W.D. Pulsed carbon dioxide laser resurfacing of photoaged facial skin. Arch. Dermatol. 132, 395–402 (1996).
    1. Ryu, H.S. , Joo, Y.H. , Kim, S.O. , Park, K.C. and Youn, S.W. Influence of age and regional differences on skin elasticity as measured by the Cutometer. Skin Res. Technol. 14, 354–358 (2008).
    1. Breternitz, M. , Flach, M. , Prassler, J. , Elsner, P. and Fluhr, J.W. Acute barrier disruption by adhesive tapes is influenced by pressure, time and anatomical location: integrity and cohesion assessed by sequential tape stripping. A randomized, controlled study. Br. J. Dermatol. 156, 231–240 (2007).
    1. Bazin, R. and Fanchon, C. Equivalence of face and volar forearm for the testing of moisturizing and firming effect of cosmetics in hydration and biomechanical studies. Int. J. Cosmet. Sci. 28, 453–460 (2006).
    1. Rawlings, A.V. and Matts, P.J. Stratum corneum moisturization at the molecular level: an update in relation to the dry skin cycle. J. Invest. Dermatol. 124, 1099–1110 (2005).
    1. Berardesca, E. , Ardigo, M. , Cameli, N. , Mariano, M. , Agozzino, M. and Matts, P.J. Randomized, double‐blinded, vehicle‐controlled, split‐face study to evaluate the effects of topical application of a Gold Silk Sericin/Niacinamide/Signaline complex on biophysical parameters related to skin ageing. Int. J. Cosmet. Sci. 37, 606–612 (2015).
    1. European Medicines Agency . Guideline on Good Pharmacovigilance Practices (GVP) (2017). Available at: , accessed 9 July 2018.
    1. Food and Drug Administration . What is a Serious Adverse Event? (2016). Available at: , Accessed 9 July 2018.

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