A Double-Blind, 12-Week Study to Evaluate the Antiaging Efficacy of a Cream Containing the NFκB Inhibitor 4-Hexyl-1, 3-Phenylenediol and Ascorbic Acid-2 Glucoside in Adult Females.

The 5 main physical manifestations of aged skin are wrinkles, uneven tone, brown spots, loss of elasticity, and dryness. One mechanism resulting in these physical manifestations is increased activity of the nuclear factor kappa B (NFκB) protein. This 12-week, double-blind, placebo-controlled, randomized split-face study compared the antiaging effect and safety of a face cream containing 4-Hexyl-1, 3-phenylenediol, an NFκB inhibitor, and ascorbic acid-2 glucoside versus placebo in adult females aged 45-70 years old. Subjects (n=42) applied active treatment or placebo to the same half face twice daily at home for 12 weeks. Clinical evaluation was carried out by a dermatologist. Subjects carried out similar self-grading assessments. Colorimetric measurements analyzed skin color, and biomechanical skin properties were evaluated. Clinical grading showed that most wrinkle parameters were significantly improved after 8 weeks of active treatment compared with baseline and placebo (P≤.05), with improvements maintained after 12 weeks. Only Marionette wrinkles did not show a significant improvement. Brown spots (color intensity/number), overall photodamage, and most complexion parameters improved significantly after 8 and 12 weeks compared with baseline and placebo (P≤.05). Self-grading yielded similar results compared with baseline. Self-grading did not demonstrate improvements with active treatment versus placebo, except for skin firmness at 8 and 12 weeks (P≤.05). A significant difference was seen with active treatment compared with placebo in all colorimetric parameters (L*, b*, and ITA°) after 8 weeks, and in spot coloration (b*) after 12 weeks (P<.05). Improvements in skin elasticity were not significantly different between treatments. Overall tolerability of active treatment was judged as good. In conclusion, a cream containing 4-Hexyl-1, 3-phenylenediol and ascorbic acid-2 glucoside improves the clinical appearance of aged skin, validating the potential use of NFκB inhibition as a novel, effective method of topical antiaging.

J Drugs Dermatol. 2016;15(6):750-758.

The skin aging index: a new approach for documenting anti-aging products or procedures.

OBJECTIVE: The overall appearance of an aged skin is characterized by a combination of several attributes such as wrinkles, brown spots and sagging. Our objective was to develop and validate a statistical framework to assess the overall anti-ageing benefits of products/procedures. METHOD: Different skin attributes were evaluated by a clinical grader and combined using a Principal Component Analysis (PCA). The Skin Ageing Index was defined as the normalized projection of the clinical grading values on the first PCA axis. Several Skin Indexes were built by grouping specific parameters related to a skin condition such as overall ageing, wrinkles and sagging. The method was validated following two steps. Firstly, a clinical study was performed on 173 Caucasian women and the correlation between the Skin Indexes and the volunteers' real and perceived age was estimated. Secondly, a double-blinded placebo-controlled randomized study was performed on 87 Caucasian women to assess the efficacy of an anti-wrinkle cream containing retinol, hyaluronic acid and dihydroxymethylchromone. Facial wrinkles were clinically evaluated and a Wrinkle Index was built. RESULTS: All indexes were highly correlated with the real and the perceived age (0.57 ≤ Pearson R ≤ 0.92, P-value ≤ 0.05). Finally, the Wrinkle Index provides documented evidence that the tested product significantly reduced the appearance of wrinkles versus the placebo and the baseline assessment (-23.53% after 4 weeks, -27.83% after 8 weeks). CONCLUSION: Skin ageing Indexes capture information relevant to the visual transformation of facial skin with age, while providing documented product benefits. These tools may enable a simpler and more consistent comparison of anti-ageing products/procedures.

Safety and efficacy of personal care products containing colloidal oatmeal.

BACKGROUND: Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vulnerable skin is of particular importance and the risk of developing further skin irritations and/or allergies should be minimized. METHODS: In a series of studies, we tested the safety of personal care products containing oatmeal (creams, cleansers, lotions) by assessing their irritant/allergenic potential on repeat insult patch testing, in safety-in-use and ocular studies using subjects with nonsensitive and sensitive skin. We also tested the skin moisturizing and repair properties of an oatmeal-containing skin care product for dry skin. RESULTS: We found that oatmeal-containing personal care products had very low irritant potential as well as a very low allergenic sensitization potential. Low-level reactions were documented in 1.0% of subjects during the induction phase of repeat insult patch testing; one of 2291 subjects developed a persistent but doubtful low-level reaction involving edema during the challenge phase in repeat insult patch testing. No allergies were reported by 80 subjects after patch testing after in-use application. Sustained skin moisturizing was documented in subjects with dry skin that lasted up to 2 weeks after product discontinuation. CONCLUSION: Our results demonstrate that colloidal oatmeal is a safe and effective ingredient in personal care products. No allergies were reported by consumers of 445,820 products sold during a 3-year period.

Methods to Assess the Protective Efficacy of Emollients against Climatic and Chemical Aggressors.

Exposure to harsh environmental conditions, such as cold and dry climate and chemicals can have an abrasive effect on skin. Skin care products containing ingredients that avert these noxious effects by reinforcement of the barrier function can be tested using in vivo models. The objective is to use in vivo models to assess the efficacy of emollients in protecting skin against climatic and chemical insults. A first model used a stream of cooled air to mimic cold wind. A second used sodium lauryl sulfate (SLS) under patch as chemical aggressor. In the model with simulated wind exposure, the untreated exposed area had a significant decrease in hydration. In contrast, application of an emollient caused a significant increase in hydration that was maintained after wind exposure. In the second model with SLS exposure, application of a barrier cream before SLS patch significantly reduced the dehydrating effect of SLS with a significant difference in variation between both areas. Application of the cream reduced TEWL, indicative of a physical reinforcement of the skin barrier. The two presented test methods, done under standardized conditions, can be used for evaluation of protective effect of emollient, by reinforcing the barrier function against experimentally induced skin dehydration.