52 years; range, 40-60 years) with mild to moderate signs of aging (laxity, crepiness, overall photodamage); subjects were randomized as to arm treatment (one with BodiFirm, the other with placebo).39 At 8 and 12 weeks, the proportion of patients with specific improvements impacting skin quality, as judged by a blinded clinical grader, was significantly greater for BodiFirm than for placebo (P≤0.05). At 12 weeks, BodiFirm treatment was associated with improvements in skin crepiness in 97% of subjects, underarm laxity in 83% of subjects, and photodamage in 83% of subjects; and BodiFirm also demonstrated significantly greater response rates versus baseline for skin roughness, firmness (visual), skin tone evenness (lack of red areas), and hyperpigmentation. However, only the percentage of responders (not the degree of improvement) was directly compared between treatments.39
In a randomized, double-blind, split-body pilot study, TransFORM Body Treatment with TriHex Technology (TBT; Alastin Skincare, Inc., Carlsbad, CA) was compared with a bland moisturizer in women (N=11; age range, 25-65 years) following cryolipolysis (CoolSculpting System; Allergan Aesthetics, an AbbVie Company, Irvine, CA) for bilateral reduction of upper arm adiposity.8 Subjects applied each treatment to opposing arms (treatment assignment was randomized) twice daily for 24 weeks post-procedure. TBT demonstrated a nonsignificant trend toward greater improvements versus the comparator in mean investigator-assessed skin laxity score (graded on a 5-point scale [0=none, 4=extreme]). The strength of the finding is constrained by the lack of statistical analysis for the investigator ratings.
Carruthers and colleagues also evaluated TBT as a standalone treatment for forearm skin quality improvement in a randomized split-body study (N=13 [4 men and 9 women]; mean age, 57 years; range, 38-74 years). Subjects applied TBT or bland moisturizer to the extensor and volar surfaces of opposing forearms (arm assignment was randomized) twice daily.40 After 3 months of treatment, TBT, compared with bland moisturizer, was associated with significant improvement in photographically assessed volar skin roughness (P=0.004) and a trend toward improvement in extensor skin roughness (P=0.174). There were no significant between-treatment differences observed with respect to skin elasticity or skin thickness, or in a patientreported assessment of wrinkle severity; however, numerical trends generally favored TBT.40
In a randomized, double-blind, split-body pilot study, TransFORM Body Treatment with TriHex Technology (TBT; Alastin Skincare, Inc., Carlsbad, CA) was compared with a bland moisturizer in women (N=11; age range, 25-65 years) following cryolipolysis (CoolSculpting System; Allergan Aesthetics, an AbbVie Company, Irvine, CA) for bilateral reduction of upper arm adiposity.8 Subjects applied each treatment to opposing arms (treatment assignment was randomized) twice daily for 24 weeks post-procedure. TBT demonstrated a nonsignificant trend toward greater improvements versus the comparator in mean investigator-assessed skin laxity score (graded on a 5-point scale [0=none, 4=extreme]). The strength of the finding is constrained by the lack of statistical analysis for the investigator ratings.
Carruthers and colleagues also evaluated TBT as a standalone treatment for forearm skin quality improvement in a randomized split-body study (N=13 [4 men and 9 women]; mean age, 57 years; range, 38-74 years). Subjects applied TBT or bland moisturizer to the extensor and volar surfaces of opposing forearms (arm assignment was randomized) twice daily.40 After 3 months of treatment, TBT, compared with bland moisturizer, was associated with significant improvement in photographically assessed volar skin roughness (P=0.004) and a trend toward improvement in extensor skin roughness (P=0.174). There were no significant between-treatment differences observed with respect to skin elasticity or skin thickness, or in a patientreported assessment of wrinkle severity; however, numerical trends generally favored TBT.40
DISCUSSION
Skin quality substantially impacts quality of life, self-esteem, and psychological health, as well as interpersonal interactions.41 In this narrative review, we have described our efforts to characterize not only the important elements of skin quality but also the key biological pathways that are crucial to restoring or repairing those elements when they are lost or compromised by aging or other causes.
The critical pathways for skin quality improvement and/or restoration spotlighted here should be considered appropriate targets for intervention via topical agents. These targeted pathways have demonstrated their central role in skin quality maintenance and restoration, and patterns of gene expression underlying these pathways have been shown to be responsive to bioactive botanical preparations.29
Clinical studies of available topical agents marketed for skin quality improvement and/or restoration have suggested their efficacy with respect to certain skin quality attributes. Based on our review of their components, the pathways targeted by the agents evaluated thus far include ECM support and restoration and lipolysis, along with autophagy, one aspect of cellular clearance and recycling. The limited target range of currently available topical agents leaves ample opportunity for development of products targeting additional pathways, potentially further improving outcomes.
The rapid growth of aesthetic procedures, including NIBC, shows no sign of abating, as outcomes improve and downtime is reduced. At the same time, “body contouring†has begun to tilt toward “body idealization,†encompassing not only NIBC and fat reduction but also desirable skin and body outcomes. Because of their potential to address multiple skin quality issues, topical products are destined to play a crucial role in achieving these outcomes, not only in the post-procedural arena but potentially as standalone products.
As the use of NIBC procedures and the range of available topical agents for skin quality improvement continue to expand, the reviewed studies have also highlighted the need to implement objective evaluations of the various skin parameters potentially affected by treatment agents, in order to supplant the current range of patient- and physician-rated evaluations as current status and outcome measures in clinical trials and clinical practice. This will involve establishing benchmarks/ranges for each assessment to define appropriate ranges for the defined parameter (ie, minimal, moderate, or severe), as well as the minimal meaningful change defining improvement/ deterioration.
One area deserving of future study is the use of topical products for skin quality improvement as adjunctive pretreatments to improve the results of NIBC procedures. This approach could conceivably reduce the incidence of undesirable post-NIBC effects (eg, bruising/ecchymosis, redness, sensitivity) and also reduce the need for post-procedure treatment.
The critical pathways for skin quality improvement and/or restoration spotlighted here should be considered appropriate targets for intervention via topical agents. These targeted pathways have demonstrated their central role in skin quality maintenance and restoration, and patterns of gene expression underlying these pathways have been shown to be responsive to bioactive botanical preparations.29
Clinical studies of available topical agents marketed for skin quality improvement and/or restoration have suggested their efficacy with respect to certain skin quality attributes. Based on our review of their components, the pathways targeted by the agents evaluated thus far include ECM support and restoration and lipolysis, along with autophagy, one aspect of cellular clearance and recycling. The limited target range of currently available topical agents leaves ample opportunity for development of products targeting additional pathways, potentially further improving outcomes.
The rapid growth of aesthetic procedures, including NIBC, shows no sign of abating, as outcomes improve and downtime is reduced. At the same time, “body contouring†has begun to tilt toward “body idealization,†encompassing not only NIBC and fat reduction but also desirable skin and body outcomes. Because of their potential to address multiple skin quality issues, topical products are destined to play a crucial role in achieving these outcomes, not only in the post-procedural arena but potentially as standalone products.
As the use of NIBC procedures and the range of available topical agents for skin quality improvement continue to expand, the reviewed studies have also highlighted the need to implement objective evaluations of the various skin parameters potentially affected by treatment agents, in order to supplant the current range of patient- and physician-rated evaluations as current status and outcome measures in clinical trials and clinical practice. This will involve establishing benchmarks/ranges for each assessment to define appropriate ranges for the defined parameter (ie, minimal, moderate, or severe), as well as the minimal meaningful change defining improvement/ deterioration.
One area deserving of future study is the use of topical products for skin quality improvement as adjunctive pretreatments to improve the results of NIBC procedures. This approach could conceivably reduce the incidence of undesirable post-NIBC effects (eg, bruising/ecchymosis, redness, sensitivity) and also reduce the need for post-procedure treatment.
DISCLOSURES
Kuniko Kadoya and Tsing Cheng are employees of AbbVie and
may own stock in the company. Janet Allenby has served on
advisory boards or received honoraria from AbbVie/Allergan,
