Title : Clinical evaluation of a new skin care regimen for hyperpigmentation
Abstract:
This 8-week clinical study evaluated the efficacy and tolerability of a new four-step regimen targeting hyperpigmentation that included an exfoliating wash and toner, used twice daily, and a moisturizing treatment used nightly, and SPF used daily. The regimen was specifically formulated with selected ingredients targeting multiple pathways associated with skin discoloration, including melanin synthesis with hexylresorcinol (HR) formulated in a toner format (1,2). Retinol, which promotes cell turnover and addresses uneven/photoaged skin (3) and niacinamide, previously shown to reduce glycated end-product accumulation in vitro (4) and reduce yellowing/hyperpigmentation (5), were also formulated separately in a moisturizing PM cream. To assist ingredient uptake, chemical exfoliation was increased with α- and β-hydroxy acids and hydration/moisturization/redness supported with witch hazel, bisabol, panthenol, glycerin, squalane, microceramides and cholesterol was also addressed in the regimen.
Methods: Thirty-four women (ages 32-75) with mild to moderate facial dullness including subjects with mild to moderate mottled facial hyperpigmentation (71%) or moderate discrete facial hyperpigmentation (62%) participated in this 8-week clinical study. Mean melanin measurements on a pigmented spot were determined by Mexameter and skin hydration by Corneometer. Local cutaneous tolerability was evaluated by assessing the objective and subjective irritation parameters globally on each subject’s face at all timepoints on a 0-3 scale. Erythema, edema, dryness and scaling/peeling were clinically graded. Burning, stinging, itching and tightness were assessed by subjects. In vitro permeation testing with human cadaver skin using a Franz diffusion cell system was used to determine delivery of HR 12 hours after application of a finite dose of formula.
Results: After 8 weeks, 85% of subjects had a statistically significant improvement in mean melanin measurements on a pigmented spot (-9.5%, p=0.002), 71% had statistically significant improvement in skin hydration (+13.8%, p=0.003), and 91% of subjects perceived the regimen as comfortable and gentle enough to use daily. Analysis of tolerability parameters showed no statistically significant change in scores for any parameter at weeks 4 or 8 when compared with baseline indicating tolerability of the regimen. No serious AE were reported. In addition, IVPT results suggest a sufficient concentration of HR was delivered to the epidermis when formulated in a toner, and therefore likely contributed to the performance of the regimen (1,2).
Conclusions: Our study demonstrated the effectiveness and tolerability of the selected ingredients formulated in a regimen format. This holistic approach allowed key ingredients to be effectively delivered to the skin as well as provide moisturization and retinoid-based cell turnover in later steps. Meaningful improvements in the appearance of discolored, uneven skin and hydration were visible and quantifiable after 8 weeks of use.
Audience Take Away:
- New data on cutaneous absorption of hexyl resorcinol will be shared.
- Audience will learn about the efficacy of a new regimen-based approach to treating hyperpigmentation.
