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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.
SUBMITTER: Hooper D
PROVIDER: S-EPMC10617894 | biostudies-literature | 2023 Oct
REPOSITORIES: biostudies-literature
Hooper Deirdre D Tedaldi Ruth R Iglesia Sofia S Young Morgann B MB Kononov Tatiana T Zahr Alisar S AS
The Journal of clinical and aesthetic dermatology 20231001 10
<h4>Objective</h4>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 <i>in vitro</i>. Secondly, to evaluate the effect of the eVCS on skin function <i>ex vivo</i>. Lastly, to evaluate eVCS and RSB in the treatment of facial hyperpigmentation and overall photodamage across a range of opposing environments.<h4>Methods</h4>MelanoDerm™ tissues were topically treated with the eVCS ...[more]