Evaluation of the Performance of a Nature-Based Sensitive Skin Regimen in Subjects With Clinically Diagnosed Sensitive Skin.

BACKGROUND: Unique whole formula nature-based sensitive skin products are formulated to minimize irritation while providing conditioning and soothing benefits to clinically diagnosed sensitive skin. OBJECTIVE: To evaluate and compare the efficacy and tolerability of a regimen of cleanser containing natural oils, beeswax, and witch hazel, and day & night creams containing natural oils, glycerin, and botanical anti-inflammatories (NR); and a synthetic dermatologist-recommended regimen of cetyl alcohol, sodium lauryl sulphate-containing cleanser and glycerin, polyisobutene-containing lotion (CR) in clinically diagnosed sensitive skin resulting from eczema/atopic dermatitis, rosacea, or cosmetic intolerance. METHODS: 120 subjects were randomized to receive either NR or CR, twice daily for 4 weeks in this double-blind study. Blinded investigator-rated and subject-rated overall skin appearance was assessed using a 5-point scale (0=none, 4=severe) at baseline, 2 weeks, and 4 weeks. Noninvasive skin assessments for skin hydration and skin barrier function were made by corneometry and TEWL, respectively. RESULTS: NR resulted in a 34% improvement from baseline in investigator-rated overall skin appearance (P less than 0.001); and CR resulted in a 4% improvement. Similar NR and CR results were found in the other efficacy parameters: tactile and visual smoothness, clarity, and radiance. Both regimens improved barrier function from baseline to week 4 (17%, 15%; NR, CR, P equals NS). NR maintained hydration from baseline to week 4 while CR increased hydration by 21% (P less than 0.001). No clinically significant tolerability issues were reported in either regimen at week 4. CONCLUSIONS: The study demonstrated that NR was effective, well tolerated, and superior to CR in the management of sensitive skin. J Drugs Dermatol. 2018;17(8):908-913.

Clinical Improvements in Very Dry Skin from a Natural Ingredient-Based Moisturizing Cream Compared With a Leading Colloidal Oatmeal Control.

The objective of this 6-week clinical study was to demonstrate the effectiveness of a natural ingredient-based moisturizing cream versus a colloidal oatmeal moisturizing cream in improving the hydration, barrier function, appearance, and feel of dry leg skin. Thirty-two subjects completed the study. After a 5-day washout, subjects used the natural ingredient-based moisturizing cream and oatmeal-containing cream on randomly-assigned legs twice a day for a period of three weeks. For the following two weeks subjects did not use any moisturizer on their legs. Skin moisture measurements showed a statistically significant increase in hydration for both products at all time points during the treatment phase of the study. Both products reduced transepidermal water loss measurements during the treatment phase of the study, showing their abilities to improve stratum corneum barrier function. Clinical evaluations showed that both products significantly decreased visual dryness and tactile roughness during the treatment phase. Improvements in the assessed clinical parameters persisted even after treatment cessation. In conclusion, the natural ingredient-based moisturizing cream was highly effective in providing moisturization and improving the skin barrier of subjects with very dry leg skin. It also produced significant improvements in visual dryness and tactile roughness that persisted during regression. Overall, these results show that the natural ingredient-based moisturizing cream delivers comparable benefits to that of a colloidal oatmeal-containing benchmark product and is an option for health care providers and consumers who seek relief from dry skin and prefer a product with all-natural ingredients. J Drugs Dermatol. 2018;17(7):758-764.

A Natural Cream-to-Powder Formulation Developed for the Prevention of Diaper Dermatitis in Diaper-Wearing Infants and Children: Barrier Property and In-Use Tolerance Studies.

INTRODUCTION: Diaper dermatitis is a common condition that develops in the diaper area due to factors such as elevated moisture, increased skin surface pH, and exposure to irritants from urine and feces. These factors suggest interventions to prevent or treat diaper dermatitis such as exposing the skin to air, frequent diaper changes, and thorough cleansing of the diaper area. Barrier creams and powders also have a role in preventing and treating diaper dermatitis. We developed a cream-to-powder product with a formula based on corn starch and other natural ingredients for use in the diaper area. METHODS: Dye exclusion study: The barrier properties of the cream-to-powder product were assessed using a dye exclusion protocol. Skin color at treated and untreated forearm sites was measured at baseline and after exposure to crystal violet stain. The cream-to-powder product's ability to inhibit the water-soluble dye from reaching the skin was judged by comparing color changes at the treated and untreated sites. Tolerance-in-use study: The safety of the cream-to-powder product was assessed in a four-week tolerance-in-use study conducted in a group of 52 diaper-wearing infants and toddlers. Subjects' parents/guardians applied the cream-to-powder product at each diaper change. A pediatrician judged safety endpoints of erythema, dryness, and edema in the diaper area at baseline and at study end. Parents/guardians also completed a questionnaire at study end. These studies have complied with Good Clinical Practices (GCP/ICH). OUTCOMES: The cream-to-powder product prevented about 70% of the test dye from reaching the skin surface, demonstrating its ability to supplement the skin barrier. The tolerance-in-use study showed no statistically significant changes in any of the safety endpoints; there were no adverse events. Parents/guardians responses to the cream-to-powder product were overwhelmingly positive. Taken together, these results support that the cream-to-powder formulation is safe and effective for helping to prevent diaper dermatitis. J Drugs Dermatol. 2018;17(5):566-570.