Title : Under eye area dark circles, puffiness and wrinkles: Efficacy and safety testing of a cosmetic product in an eight-week clinical study
Abstract:
Under eye dark circles commonly seen in both sexes, make one look older and thus are a significant cosmetic concern. Multiple factors including melanin deposition, post-inflammatory hyperpigmentation secondary to atopic/allergic contact dermatitis, periorbital edema, superficial vasculature, and shadowing due to skin laxity, stress, sleep deprivation are responsible for under eye dark circles. Besides expensive HA fillers and lasers, current and new, comparatively cheaper, topical treatment options are available. Speeding healing of the under-eye area with products backed by clinical testing, makes the future of dark circle treatments unabatedly positive.Our objective was to determine the efficacy and safety of a topical under-eye cosmetic product in subjects with periorbital hyperpigmentation, puffiness, crow’s feet, lines/wrinkles, in an eight-week clinical design. 35 healthy F(35-65y) meeting study criteria, with no eye treatment in past 6M, who gave written informed consent were enrolled. Subjects applied the test article twice daily for eight weeks. No other treatment or excessive exposure to sunlight was allowed. Visual evaluations for under eye dark circles, puffiness and crow’s feet (lines/wrinkles) by an expert grader along with bioinstrumentation (Colorimeter for color), (Corneometer for hydration) at baseline, Weeks 4 and 8. Self-perception assessments and digital images were obtained at baseline and various time points using the VISIA® CR Imaging System-Canfield. Adverse events, if any, were also collected.Our results showed significant decrease under eye dark circles, in crow’s feet (lines/wrinkles), under eye puffiness and increase in skin hydration with no related AE’s. SPQ’s analyses showed high level of satisfaction with the test article. Our study demonstrates the safety and effectiveness of the under-eye treatment with skin rejuvenation following decrease of periorbital hyperpigmentation puffiness, crow’s feet (lines/ wrinkles) in skin hydration with no related AE’s. SPQ’s analyses showed high level of satisfaction with the test article.
Conclusion: Our study demonstrates the safety and effectiveness of the under-eye treatment with clinical scoring, bio-instrumentation and colour analyses with colorimeter and VISIA. The techniques used in assessing under eye dark circles were useful with good co-relation seen to exist between them. Therefore, addition of a topical under eye cream to existing skin care routine can protect and reduce under eye skin area damage. Our study provides valuable insight for under eye treatment, and can serve as a basis for developing future strategies for cosmetic treatment of this concern across different skin tones.
