Efficacy and Tolerability of a Novel Topical Treatment for Neck: A Randomized, Double-blind, Regimen-Controlled Study

February 2021 | Volume 20 | Issue 2 | Original Article | 184 | Copyright © February 2021


Published online January 19, 2021

Elizabeth T. Makino BS CCRA MBA,a Kuniko Kadoya PhD,a Robin Chung MS,a Lily Jiang PhD,b Mouna Mikati PhD,a Rahul C. Mehta PhDa

aSkinMedica - Allergan Aesthetics, an AbbVie Company, Irvine, CA
bSGS Stephens Inc., Richardson,TX

cellular components and an exacerbated intrinsic aging process.16,17 NCC treatment resulted in upregulation of various genes related to proteasome assembly and function (POMP, PSMB5, PSMB6), different stages of autophagy (ATG5, ATG7, ATG12, BECN1), and protein folding and stabilization (HSPA8) suggesting that NCC helps maintain proteostasis and mitigate intrinsic aging processes to support a healthier and more youthful appearance of the neck and décolletage.

CONCLUSION

Rejuvenation of neck skin requires a differentiated approach that is tailored to the neck’s specific characteristics. Designed to address the signs of skin aging of the neck and décolletage, NCC significantly improved skin laxity/sagging, firmness and elasticity of the neck, as well as overall appearance and skin quality of both the neck and décolletage area. The clinical findings from this double-blind, regimen-controlled study were corroborated by in vitro analysis in human 3D skin models demonstrating stimulation of neocollagenesis and neoelastogenesis as well as support of cellular proteostasis, providing insights on possible mechanisms of action for the observed clinical outcomes.

DISCLOSURES

Financial support for these studies were provided by Allergan Aesthetics, Inc., an AbbVie Company. Ms. Makino, Dr. Kadoya, Ms. Chung, Dr. Mikati, and Dr. Mehta are employees of Allergan Aesthetics, Inc., an AbbVie Company.

ACKNOWLEDGMENT

The authors gratefully acknowledge Phillip Lai for technical support.

Data Sharing
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (e.g. protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

This clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement. Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html.

REFERENCES

  1. Rohrich RJ, Rios JL, Smith PD, et al. Neck rejuvenation revisited. Plast Reconstr Surg. 2006;118:1251-63.
  2. Ferreira T, Cestari, Dantas LP, et al. Acquired hyperpigmentations. An Bras Dermatol. 2014;89(1):11-25.
  3. Burke KE. Mechanisms of aging and development- a new understanding of environmental damage to the skin and prevention with topical antioxidants. Mech Ageing Dev. 2018;172:123-130
  4. Kim E, Cho G, Won NG, et al. Age-related changes in skin bio-mechanical properties: the neck skin compared with the cheek and forearm skin in Korean females. Skin Res Technol. 2013;19:236-41.
  5. Ha RY, Nojima K, Adams WP Jr, et al. Analysis of facial skin thickness: defining the relative thickness index. Plast Reconstr Surg. 2005;115 (6):1769- 1773.
  6. Perez MI. An anatomic approach to the rejuvenation of the neck. Dermatol Clin. 2001;19(2):387-396.
  7. Weiss L. Cell and Tissue Biology: A Textbook of Histology. 6th ed. Baltimore: Urban & Schwarzenberg. 1988.
  8. Tsukahara K, Takema Y, Moriwaki S, et al. Selective inhibition of skin fibroblast elastase elicits a concentration-dependent prevention of ultraviolet B-induced wrinkle formation. J Invest Dermatol. 2001;117:671-677.
  9. Koga, et al. Protein homeostasis and aging: The importance of exquisite quality control. Ageing Res Rev. 2011;10:205-215.
  10. Tanaka K. The proteasome: Overview of structure and functions. Proc Jpn Acad Ser B Phys Biol Sci. 2009;85:12-36.
  11. Weinkle S, Saco M. Approach to the mature cosmetic patient: Aging gracefully. J Drugs Dermatol. 2017;16(6):s84-s86.
  12. Vanaman M, Fabi SG, Cox SE. Neck rejuvenation using a combination approach: our experience and a review of the literature. Dermatol Surg. 2016; 42 Suppl 2:S94-S100.
  13. S. Sun, M.A. Karsdal, in Biochemistry of Collagens, Laminins and Elastin, 2016.
  14. Bönnemann C. The collagen VI-related myopathies: muscle meets its matrix. Nat Rev Neurol. 2011;7:379–390.
  15. Cescon M, Gattazzo F, Chen P, et al. Collagen VI at a glance. J Cell Sci. 2015;128: 3525-3531.
  16. López-Otín C, Blasco M, Partridge L, et al. The hallmarks of aging. Cell. 2013;153:1194-1217.
  17. Vilchez D, Saez I, Dillin A. The role of protein clearance mechanisms in organismal ageing and age-related diseases. Nat Commun. 2014;5:5659.

AUTHOR CORRESPONDENCE

Mouna Mikati PhD mouna.mikati@allergan.com