RESUMO
Purpose: A double-blind, placebo-controlled, randomized, proof-of-concept trial aimed to evaluate the efficacy and safety of VerbasnolTM [Rehmannia glutinosa Libosch leaf-based extract (RGLE)] in females, with moderate to severe acne vulgaris. Participants and Methods: Twenty-two females aged 18 to 35 years having moderate to severe acne with Global Acne Grading System (GAGS) scores of 19 to 38 were included in the study and were randomized in a 1:1 ratio to receive either one capsule (100 mg/day) of RGLE or placebo orally after breakfast for 56 days. The primary outcome was a change in acne severity measured by the GAGS compared to the placebo on day 56. The secondary outcomes were changes in the number of inflammatory acne lesions, facial sebum secretion, quality of life, local pain and itching, skin wrinkle severity, and other skin characteristics, including radiance, luminosity, smoothness, texture, firmness, and hydration. Additionally, the percentage of responders and global tolerability and efficacy were evaluated. Results: The mean GAGS score was reduced by 21.72% and 14.20% on day 28 in RGLE (n=10) and placebo groups (n=12), respectively, which further reduced in both groups on day 56. The RGLE group reported better improvement in other skin characteristics on day 56. No safety or tolerability concerns were reported for the extract. RGLE reduced acne and improved the skin quality in females compared to placebo as early as 28 days of supplementation. Conclusion: RGLE supplementation at a dose of 100 mg/day has provided a clinically relevant decrease in acne severity and improved the skin hydration and quality of life of the participants with acne after 56 days of dose administration.
RESUMO
Background: The skin is primarily affected by aging, especially when it is exposed to particulate matter present in the environment. It has been hypothesized that consumption of products with known antioxidant properties would help combat factors associated with both intrinsic and extrinsic aging factors. Objective: The aim of the present study was to evaluate the effect of the formulation Blue Fenugreek Kale Extract (BFKE) on skin aging. Methods: In this study, the effect of BFKE on protein oxidation was determined in human dermal fibroblasts by analysis of the level of protein carbonylation after cells were stressed with either H2O2 or urban pollution consisting of particulate matter and UV-A. Furthermore, a randomized, double-blind, placebo-controlled clinical study that evaluated the effect of BFKE consumption over a period of 56 days in 59 volunteers was performed. The major parameter studied was skin barrier dysfunction through the assessment of Transepidermal Water Loss (TEWL). Additional parameters analyzed clinically include skin moisture content, participant self-assessment of skin parameters, wrinkle severity, skin sagging and elasticity. Furthermore, low grade and allergic inflammatory biomarker levels were measured at the start and end of the treatment period, along with oxidative stress assessment using blood malondialdehyde levels. Results: BFKE significantly reduced protein carbonylation in human dermal fibroblasts stressed with urban pollution. In the clinical study, the TEWL level reduced significantly and at the same time the skin moisture content levels increased by end of the treatment period. No significant changes were observed in wrinkle severity, skin sagging, elasticity, inflammatory and oxidative stress biomarker levels. Participant and investigator perception of treatment was significantly greater after product consumption, as was the improvement in skin parameters based on participant self-assessment. Conclusion: BFKE reduces protein oxidation induced by H2O2 and restores skin barrier function and skin hydration, while also combating early signs of aging.
