Evaluation of the clinical efficacy and safety of Under Eye Cream in the treatment of Under Eye Dark Circles and Pigmentation

摘要

Aim : This study was planned to evaluate the clinical efficacy and safety (short- and long-term) of Under Eye Cream (Batch No. FD/UE/63) in the management of under eye dark circles, pigmentation, wrinkles, and under eye puffiness.Material and Methods : It was a prospective, open, non-comparative, phase III clinical trial. A total of 50 patients, who were diagnosed as suffering from moderate to severe form of under eye dark circles and pigmentation, were included in the study. A baseline history was obtained in order to determine the patient's eligibility for enrolment in the trial. All the patients were advised to apply and massage the Under Eye Cream into the skin around the eyes twice daily for a period of 6 weeks. All the patients were followed-up for a period of 6 weeks. Clinical assessment of under eye dark circles and pigmentation lesions was done objectively (by doctor) and also subjectively (by patient). The severity of symptoms was evaluated using 0-3 grading scale (0=Nil, l=Mild, 2=Moderate, 3=Severe). All 50 patients (42 female, 8 male) completed the study. Statistical analysis of all the data obtained at the end of the study was done by using repeated measures of ANOVA by Friedman test followed by Dunnett's Multiple Comparison Posthoc test to find out the level of significance.Results : There was highly significant reduction in the mean score of under eye dark circles in all patients at the end of the study. Also there was significant reduction in the mean scores of erythema, scaling, pruritus, puffiness, wrinkles, laxity of skin, and pigmentation. This study observed significant symptomatic and clinical improvement in under eye dark circles and pigmentation in 6 weeks.Conclusion : The excellent action of Under Eye Cream might have been due to synergistic actions of its ingredients Bergenia ligulata, Cipadessa baccifera, and oil of Triticum sativum. None of the patients exhibited any adverse reactions. Thus, it may be concluded that Under Eye Cream is effective and safe in the management of under eye dark circles and pigmentation.