For the décolletage, NCC provided significant improvements in fine lines/wrinkles and tactile roughness at all follow-up visits, and in coarse lines/wrinkles, hyperpigmentation, skin tone evenness, and radiance at weeks 8 and 12, compared to baseline (all P≤0.035; Wilcoxon signed rank test; Figure 5).
Investigator’s global improvement assessment showed significant improvements over control at weeks 8 and 12 in neck skin laxity/sagging and overall skin texture (including pronounced, extensive visible skin roughness, lines/wrinkles, laxity and crepey/crinkled appearance) (P≤0.009; Wilcoxon rank sum test). Compared to baseline, the NCC-treatment group showed significant global improvements in overall skin texture on the neck and in overall photodamage on the décolletage at all follow-up visits (all P≤0.002; Wilcoxon signed rank test). Improvements were observed in the control group but did not reach significance until week 12 for skin texture (P≤0.016; Wilcoxon signed rank test), and week 8 for overall photodamage on the décolletage (P≤0.031; Wilcoxon signed rank test). Representative photographs of treatment responses observed by investigator and subjects are shown in Figures 6–9.
Three subjects reported potential treatment-related mild/moderate adverse events (erythema/rash/burning sensation): two subjects in the NCC-treatment group and one subject in the control group.The adverse events (AE) all resolved without sequelae. One of the subjects in the NCC-treatment group discontinued due to the AE and was not included in the intent to treat analysis.
Cutometer measurements demonstrated statistically significant improvements in extensibility (decreased extensibility indicates reduced ability of skin to be extended or stretched), maximum recovery area (decreases with increased firmness of the skin), resiliency, pure elasticity, total recovery (overall elasticity), and elastic recovery for the NCC-treatment group at week 12 when compared to baseline (all P≤0.035; Wilcoxon signed rank test; Figure 10). NCC-treatment group showed consistently greater improvements numerically over control. The control group showed significant improvements in extensibility and maximum recovery area at week 12, while biological elasticity and viscoelastic recovery did not change for either group (Figure 10). Altogether, these results indicate an overall increase in skin elasticity and firmness.
Subject self-assessment questionnaires support the investigator-observed improvements in neck and décolletage with a significant proportion of subjects agreeing that NCC made their neck look and feel firmer, reduced the appearance of lines and wrinkles, and improved skin texture at all follow-up visits (all P≤0.007; binomial test). Furthermore, NCC product attributes were highly rated by subjects (100% of subjects agreed) for texture, ease of application, skin absorption, as well as skincare regimen compatibility and convenience.
Investigator’s global improvement assessment showed significant improvements over control at weeks 8 and 12 in neck skin laxity/sagging and overall skin texture (including pronounced, extensive visible skin roughness, lines/wrinkles, laxity and crepey/crinkled appearance) (P≤0.009; Wilcoxon rank sum test). Compared to baseline, the NCC-treatment group showed significant global improvements in overall skin texture on the neck and in overall photodamage on the décolletage at all follow-up visits (all P≤0.002; Wilcoxon signed rank test). Improvements were observed in the control group but did not reach significance until week 12 for skin texture (P≤0.016; Wilcoxon signed rank test), and week 8 for overall photodamage on the décolletage (P≤0.031; Wilcoxon signed rank test). Representative photographs of treatment responses observed by investigator and subjects are shown in Figures 6–9.
Three subjects reported potential treatment-related mild/moderate adverse events (erythema/rash/burning sensation): two subjects in the NCC-treatment group and one subject in the control group.The adverse events (AE) all resolved without sequelae. One of the subjects in the NCC-treatment group discontinued due to the AE and was not included in the intent to treat analysis.
Cutometer measurements demonstrated statistically significant improvements in extensibility (decreased extensibility indicates reduced ability of skin to be extended or stretched), maximum recovery area (decreases with increased firmness of the skin), resiliency, pure elasticity, total recovery (overall elasticity), and elastic recovery for the NCC-treatment group at week 12 when compared to baseline (all P≤0.035; Wilcoxon signed rank test; Figure 10). NCC-treatment group showed consistently greater improvements numerically over control. The control group showed significant improvements in extensibility and maximum recovery area at week 12, while biological elasticity and viscoelastic recovery did not change for either group (Figure 10). Altogether, these results indicate an overall increase in skin elasticity and firmness.
Subject self-assessment questionnaires support the investigator-observed improvements in neck and décolletage with a significant proportion of subjects agreeing that NCC made their neck look and feel firmer, reduced the appearance of lines and wrinkles, and improved skin texture at all follow-up visits (all P≤0.007; binomial test). Furthermore, NCC product attributes were highly rated by subjects (100% of subjects agreed) for texture, ease of application, skin absorption, as well as skincare regimen compatibility and convenience.
DISCUSSION
The neck is gaining attention as it plays a telling role as an age indicator, and patients are increasingly seeking treatment options for a younger-looking neck to achieve an overall more aesthetically pleasing look.11 Because of differences in structure and function compared to facial skin, neck skin ages differently and special considerations should be taken when providing treatment. Though mostly similar procedural modalities can be used to treat both neck and facial skin,12 neck skin is not prioritized in skincare and the limited topical treatment options available often have little (pre-)clinical data to support anti-aging claims specific to the signs of skin aging on neck and décolletage. Utilizing a formulation optimized through pre-clinical research, the NCC was clinically proven to be effective and well-tolerated in significantly improving multiple key skin quality parameters of the neck and décolletage including laxity/sagging, crepiness and skin tone evenness, supported by blinded investigator assessments as well as objective cutometer measurements.
It is well established that intrinsic and extrinsic aging lead to significant degradation of ECM components such as collagen and elastic fibers. Because of its anatomy, neck skin is more prone to the degradation of these structural fibers losing its elasticity faster with age compared to facial skin, which results in accelerated sagging and deeper wrinkle formation.4 Supporting ECM components production as well as protection against further degradation while specifically addressing the dermal elastic fibers and DEJ that play vital roles in maintaining skin elasticity and firmness13 is required to provide robust visible neck skin rejuvenation effects. The presented in vitro data demonstrated that NCC reduces elastase levels and induces the gene expression of key ECM components including elastin, fibrillin 1, fibulin 5, microfibrillar-associated protein 1, and lysyl oxidase-like protein 1 (ELN, FBN1, FBLN5, MFAP1, LOXL-1), which govern the formation of healthy and functional elastic fibers. Collagen type VII (COL7A1) forms anchoring filaments in the basement membrane of the DEJ. Collagens type I and III (COL1A1 and COL3A1) constitute most of the dermis providing skin its firmness and strength for a more youthful appearance, and decorin (DCN) is a proteoglycan that is important for proper collagen fiber alignment. Collagen type VI (COL6A1) is a major component of skeletal muscle ECM and thus, is involved in health and function of muscle fibers.14,15 Supporting COL6A1 expression can be of particular relevance to improving the overall appearance of aged neck skin since accentuation of platysma muscle protrusion and platysmal bands on the neck mid-line could be tied to weakening and loss of tissue and fibers that connect muscle to the overlying skin.
The proteasome and autophagy systems are part of the cellular recycling mechanism that ensures orderly degradation of damaged, dysfunctional, and misfolded proteins and cellular components to maintain cellular proteostasis. Aging alters the activity of these systems leading to accumulation of damaged
It is well established that intrinsic and extrinsic aging lead to significant degradation of ECM components such as collagen and elastic fibers. Because of its anatomy, neck skin is more prone to the degradation of these structural fibers losing its elasticity faster with age compared to facial skin, which results in accelerated sagging and deeper wrinkle formation.4 Supporting ECM components production as well as protection against further degradation while specifically addressing the dermal elastic fibers and DEJ that play vital roles in maintaining skin elasticity and firmness13 is required to provide robust visible neck skin rejuvenation effects. The presented in vitro data demonstrated that NCC reduces elastase levels and induces the gene expression of key ECM components including elastin, fibrillin 1, fibulin 5, microfibrillar-associated protein 1, and lysyl oxidase-like protein 1 (ELN, FBN1, FBLN5, MFAP1, LOXL-1), which govern the formation of healthy and functional elastic fibers. Collagen type VII (COL7A1) forms anchoring filaments in the basement membrane of the DEJ. Collagens type I and III (COL1A1 and COL3A1) constitute most of the dermis providing skin its firmness and strength for a more youthful appearance, and decorin (DCN) is a proteoglycan that is important for proper collagen fiber alignment. Collagen type VI (COL6A1) is a major component of skeletal muscle ECM and thus, is involved in health and function of muscle fibers.14,15 Supporting COL6A1 expression can be of particular relevance to improving the overall appearance of aged neck skin since accentuation of platysma muscle protrusion and platysmal bands on the neck mid-line could be tied to weakening and loss of tissue and fibers that connect muscle to the overlying skin.
The proteasome and autophagy systems are part of the cellular recycling mechanism that ensures orderly degradation of damaged, dysfunctional, and misfolded proteins and cellular components to maintain cellular proteostasis. Aging alters the activity of these systems leading to accumulation of damaged
