Ovolux™ Brand Eggshell Membrane Reduces the Clinical Signs of Aging by Improving Skin, Hair & Fingernail Appearance, Texture, and Biomechanical Properties: A Single Center, Randomized, Double Blind, Placebo Controlled Clinical Trial
- 1 ESM Technologies, LLC, Carthage, USA
- 2 ESM Technologies, LLC, Carthage, USA
- 3 Phytonet AG, Schindellegi, Switzerland
- 4 ESM Technologies, LLC, Carthage, USA
Abstract
Background: As the population of people aged 65 and older increases, greater attention is being paid to issues surrounding skin aging. This study was conducted to evaluate the efficacy of an oral unhydrolyzed eggshell membrane (ESM) ingredient (branded Ovolux™) versus placebo on both objective and subjective markers of skin aging in middle-aged and senior adults, and also to assess the possible benefits of Ovolux™ on the health of hair and fingernails. Methods: Sixty-three healthy, men and women (aged 35 - 66) were randomly assigned to receive either oral ESM 300 mg (n = 32) or placebo (n = 31) once daily for 12 weeks. The primary endpoint was any statistically significant improvement in skin elasticity in the anterior region of the temporal fossa of the face versus placebo evaluated at 12 weeks of treatment based upon measurements taken with the Cutometer® MPA 580 multi-probe system. Secondary endpoints were improvement in skin firmness, viscoelasticity, hydration, or trans-epidermal water loss versus placebo. Additional secondary endpoints were any improvement in skin, hair, or fingernail subjective parameters versus placebo as determined via Patient’s Assessments. Results: Supplementation with Ovolux™ ESM produced a significant absolute treatment effect (TE abs ) versus placebo after both six weeks (TE abs +8.4%, p = 0.019) and twelve weeks of treatment (TE abs +12.2%, p = 0.002) for the primary outcome measure total elasticity (R2). There were also significant treatment responses versus placebo for the objective measures of firmness (R0), net elasticity (R5), and viscoelasticity (R6) at both timepoints (R0: Week 6, − 23.9%; Week 12, − 16.8%) (R5: Week 6, +9.5%; Week 12, +10.6%) (R6: Week 6, −17.9%; Week 12, −17.7%), as well as for skin hydration versus placebo at both 6 weeks (+8.3%) and 12 weeks (+8.6%) of treatment. There were also significant improvements in the ESM treatment group versus placebo in the subjective measures of skin appearance, skin texture, overall skin health, hair texture, and overall hair health as determined by patient assessments. Conclusions: Ovolux™ provided significant broad-based improvements in critical biomechanical skin properties versus placebo, including elasticity, firmness, and viscoelasticity. These effects, along with improvement in skin hydration, were observed as early as 6 weeks and continued through the end of the 12-week study. Treatment with ESM was reported to be well-tolerated. Ovolux™ ESM appears to be a natural solution to help skin to resist the epidermal thickening, the dermal thinning, and the skin laxity and elastosis found in intrinsically aging skin. The Clinical Trial Registration number is: NCT06148337.
- Department of Economic and Social Affairs (2023) World Social Report 2023: Leaving No One Behind in an Ageing World.
- Wong, Q.Y.A. and Chew, F.T. (2021) Defining Skin Aging and Its Risk Factors: A Systematic Review and Meta-Analysis. Scientific Reports , 11, Article No. 22075. https://doi.org/10.1038/s41598-021-01573-z
- Sampaio, A.L., Bressan, A.L., Vasconcelos, B.N. and Gripp, A.C. (2021) Skin Manifestations Associated with Systemic Diseases—Part I. Anais Brasileiros de Dermatologia , 96, 655-671. https://doi.org/10.1016/j.abd.2021.02.008
- Leal, J.M., de Souza, G.H., Marsillac, P.F.D. and Gripp, A.C. (2021) Skin Manifestations Associated with Systemic Diseases—Part II. Anais Brasileiros de Dermatologia , 96, 672-687. https://doi.org/10.1016/j.abd.2021.06.003
- Kolarsick, P.A.J., Kolarsick, M.A. and Goodwin, C. (2011) Anatomy and Physiology of the Skin. Journal of the Dermatology Nurses ’ Association , 3, 203-213. https://doi.org/10.1097/jdn.0b013e3182274a98
- Oh, J., Kim, Y.K., Jung, J., Shin, J. and Chung, J.H. (2011) Changes in Glycosaminoglycans and Related Proteoglycans in Intrinsically Aged Human Skin in Vivo . Experimental Dermatology , 20, 454-456. https://doi.org/10.1111/j.1600-0625.2011.01258.x
- Baumann, L. (2007) Skin Ageing and Its Treatment. The Journal of Pathology , 211, 241-251. https://doi.org/10.1002/path.2098
- Papanagiotou, V.D. (2009) Skin Aging and Photoaging. Dermattikon , 4, 57-65.
- Helfrich, Y.R., Sachs, D.L. and Voorhees, J.J. (2008) Overview of Skin Aging and Photoaging. Dermatological Nursing , 20, 177-183.
- Wong, M., Hendrix, M.J.C., von der Mark, K., Little, C. and Stern, R. (1984) Collagen in the Egg Shell Membranes of the Hen. Developmental Biology , 104, 28-36. https://doi.org/10.1016/0012-1606(84)90033-2
- Arias, J.L., Fernandez, M.S., Dennis, J.E. and Caplan, A.I. (1991) Collagens of the Chicken Eggshell Membranes. Connective Tissue Research , 26, 37-45. https://doi.org/10.3109/03008209109152162
- Makkar, S., Liyanage, R., Kannan, L., Packialakshmi, B., Lay, J.O. and Rath, N.C. (2015) Chicken Egg Shell Membrane Associated Proteins and Peptides. Journal of Agricultural and Food Chemistry , 63, 9888-9898. https://doi.org/10.1021/acs.jafc.5b04266
- Ahmed, T.A.E., Suso, H. and Hincke, M.T. (2017) In-Depth Comparative Analysis of the Chicken Eggshell Membrane Proteome. Journal of Proteomics , 155, 49-62. https://doi.org/10.1016/j.jprot.2017.01.002