An Open Label Clinical Trial to Evaluate the Efficacy and Tolerance of a Retinol and Vitamin C Facial Regimen in Women With Mild-to-Moderate Hyperpigmentation and Photodamaged Facial Skin

significant proportion of subjects responded favorably regarding the efficacy of the test product. Specifically, after 12 weeks:

90% of subjects thought their skin texture was improved

93% of subjects felt that their skin tone appeared more even

72% of subjects thought their brown spots were less noticeable

93% of subjects felt that their face looked more radiant or brighter

75% of subjects thought their skin was less red in color

90% of subjects thought the fine lines on their skin were less noticeable

88% of subjects felt the wrinkles on their face were less noticeable

90% of subjects thought their skin looked and felt more healthy

86% of subjects felt their skin looked younger and firmer

86% of subjects reported that their skin felt more moisturized

93% of subjects though the appearance of their skin was improved overall.

A statistically significant proportion of subjects reported positively regarding the product aesthetics by week 12. Specifically:

86% of subjects felt that that the products moisturized their skin

90% of subjects thought that the products’ scent was pleasant

93% of subjects felt that the products’ texture was pleasant

93% of subjects thought that the products did not leave an unpleasant after-feel

95% of subjects felt that applying the products was a pleasant experience

93% of subjects thought that the products were mild and did not irritate the skin

86% of subjects reported that they would like to purchase the products

Overall, 13 subjects experienced a total of 30 non-serious adverse events (AEs) that were deemed to be definitely related to the product regimen. These included exfoliation (n=12), erythema (n=7), burning sensation (n=6), pruritus (n=2), pain of skin (n=1), dry skin (n=1), and tenderness of skin (n=1). All of the symptoms are expected reactions to the use of retinol product. All AEs were mild-to-moderate, and all resolved with time as skin became acclimated to 0.5% retinol treatment or with modified use of the test material.

Overall, the results of this open-label, single-center clinical usage trial indicate that the use of the dual product regimen (0.5% retinol treatment and anti-aging moisturizer with 30% vitamin C) was effective in improving aged facial skin when used over the course of 12 weeks by women with mild-to-moderate facial hyperpigmentation and photodamage. The facial regimen produced a statistically significant decrease (improvement) in clinical grading scores for all parameters assessed including: clarity/brightness, fine lines, evenness of skin tone (redness), firmness, global hyperpigmentation (mottled), global hyperpigmentation (discrete), overall photodamage, radiance, skin tone (color) evenness, tactile smoothness, visual smoothness, and wrinkles at weeks 8 and 12 when compared with baseline scores. In addition, the majority of these parameters also were improved at week 4.

Of note, the 0.5% retinol treatment test product contained encapsulated retinol, which enhances stability, reduces irritation, and allows for sustained released of retinol onto the skin for optimal efficacy of the product.^7,8 It also included bakuchiol, a broad-spectrum antioxidant which has a stabilizing and an efficacy boosting effect on retinol,^9-14 as well as Ophiopogon japonicus root extract to enhance skin barrier function and increase the skin’s own natural moisturizing factor.15 The anti-aging moisturizer with 30% vitamin C (THD ascorbate) works with retinol to improve antioxidant and anti-aging activity.^17-19 The anti-aging moisturizer with 30% vitamin C also contained vitamin E and ubiquinone (coenzyme Q10), antioxidants, which reduce free radical formation.¹⁵ The combination of these effective ingredients are thought to result in an improvement in the signs of aging around the facial skin. This study appears to positively support this hypothesis, as illustrated by the photos shown in Figures 4 and 5.