In Vitro, Ex Vivo and Clinical Trial of Brightening Serum Using a Novel Delivery System on Subjects With Moderate to Severe Dyschromia.

BACKGROUND/AIMS: Pigmentary problems are common and can arise from sun exposure, skin inflammation, changes in hormones, and certain medications. Because they are visible, these pigmentary problems can be very distressing for individuals, and they are often challenging to manage. Three studies were conducted, ex vivo, in vitro, and in vivo.

SUBJECTS/

METHODS

An in vitro study of brightening/lightening in skin models; an ex vivo skin study using Raman spectroscopy; and a 12-week clinical study of a novel complexion brightening serum with Tiered-Release Vesicle (CBS-TRV) delivery technology in adults with moderate to severe photodamage and uneven skin tone. Assessments included clinical grading, melanin and erythema measurements by Mexameter, digital imaging, and a patient self-assessment questionnaire. Standard safety and tolerability assessments were also performed.

RESULTS

The in vitro 3D skin study showed that a 2 μL/cm2 application of CBS-TRV (the recommended and clinical application volume) slowed melanin production by 37.5% compared to untreated tissues after 2 weeks. Furthermore, Raman spectroscopy provided evidence for tranexamic acid penetration into the epidermis of ex vivo human skin. Clinical grading revealed significant improvements at the majority of visits, which were accompanied by improvements of erythema index and melanin index on mexameter. In addition, subjects provided positive feedback regarding the clinical results as well as the formulation's aesthetics. Finally, the CBS-TRV product was safe and well tolerated.

CONCLUSIONS

The multiple active ingredients in CBS-TRV target melanogenesis in a variety of ways, and both in vitro and clinical studies demonstrated significant improvements in skin tone and pigmentation.