ABSTRACT
Objective: The objective of this study is three-fold. Firstly, to evaluate an enhanced vitamin C serum (eVCS) and its' combination with a retinol-bakuchiol serum (RBS) on pigmentation in vitro. Secondly, to evaluate the effect of the eVCS on skin function ex vivo. Lastly, to evaluate eVCS and RSB in the treatment of facial hyperpigmentation and overall photodamage across a range of opposing environments. Methods: MelanoDerm™ tissues were topically treated with the eVCS, and a eVCS and RSB blend for 14 days, and then a melanin assay was performed. Surgical waste facial skin explants were incubated with the eVCS or control for five days and then fixed and stained for skin physiology and structure. A 12-week, IRB approved, study on female subjects (n=29, aged 35 to 65) with moderate global facial hyperpigmentation and overall photodamage was completed. Clinical assessment, tolerability measurements, and subject-assessments were performed baseline at Weeks 6, 8, and 12. Investigator Global Aesthetic Improvement Score was completed at Week 12. Results: The eVCS-treated facial skin explants achieved a significant 145 percent collagen increase compared to control. The eVCS-RSB combination proved synergistic in reducing melanin compared to the eVCS alone. The eVCS-RSB combination demonstrated significant clinical improvement at all timepoints and was well tolerated. Subject responses were favorable and GAIS score of 3.0 was achieved at Week 12, indicating an improvement. Limitations: Limitations include lack of placebo or vehicle control. Conclusion: The product pairing, eVCS and RSB, offers patients an efficacious and well-tolerated treatment to target pigmentation and photodamage. Clinical Trial: This study, Pro00050557, was approved by Advarra IRB (Columbia, Maryland) and submitted to ClinicalTrials.gov #: NCT05423873.
ABSTRACT
BACKGROUND: Aging of neck and jawline skin is caused by intrinsic and extrinsic factors and is evidenced by wrinkling, laxity, skin dyspigmentation, loss of the mandibular contour, accumulation of submental fat, density loss, and prominent platysma bands. Early intervention with topical cosmeceuticals, especially in younger subjects with "tech neck," can offer a solution and potentially mitigate aging of the neck and jawline. AIM: The objective of this prospective, open-label, single-center clinical study was to assess the efficacy and tolerability of a topical anti-aging neck treatment (TNT) in a cohort of Chinese women with mild to moderate signs of aging on the neck and jawline. SUBJECTS/METHODS: This study was approved by an ethics committee and involved healthy Chinese subjects. Thirty-five female subjects, 25-50 years old, with mild to moderate signs of aging of the neck and jawline were recruited. Subjects applied the TNT to the neck and jawline twice daily for 84 days. Long-term efficacy and tolerability, clinical photography, bioinstrumentation, and a self-assessment questionnaire were performed at baseline and post-baseline. RESULTS: The TNT significantly improved horizontal neck fold lines and neck skin elasticity, hydration, gloss/radiance, and skin tone evenness post-baseline. Clinical photography and ultrasound corroborated these findings. The product was well perceived and well tolerated by subjects. CONCLUSION: This study demonstrated the TNT was effective against both extrinsic and intrinsic aging of the neck and jawline. The TNT provides a topical solution for Chinese women concerned with an aging appearance of the neck including "tech neck."
