An open-label, single-arm clinical study to evaluate efficacy and safety of Nyumi radiant skin gummies in healthy adult subjects with fine lines/wrinkles, hyperpigmentary spots, and under eyes dark circles

Author:

Karmase Aniket1,Agarwal Ananya1,Patel Bhagirath2,Joshi Parth2,Sethi Simran2,Shrivastava Anshu2

Affiliation:

1. Department of Research and Development, Ikaria Wellness Pvt. Ltd., Mumbai, Maharashtra, India

2. Consumer Research, Cliantha Research, Sigma I Corporates, Ahmedabad, Gujarat, India,

Abstract

Objectives: Flawless skin is certainly the most desired feature that plays a vital cosmetic role in human being. Apart from protecting our body from environmental factors, it also protects the body from water loss and infection-causing microorganisms. However, the skin condition changes due to various ageing factors. The present study was conducted to assess the safety and efficacy of multivitamin and nutraceutical ingredients-based gummies in adult human participants. Material and Methods: An open-label, single-arm clinical study was conducted on 36 enrolled healthy males and females (in ratio of 1:2) between 20 and 65 years of age to evaluate the efficacy and safety of the study product in healthy adult subjects with fine lines/wrinkles, hyperpigmentary spots, and under eyes dark circles. All eligible subjects consumed the test product for 75 days. They underwent clinical evaluation by dermatologist, instruments evaluation, and subjective evaluation. Results: Thirty two (n = 32) subjects completed all study visits. The study product, when consumed for 75 days, was found to be efficacious in reducing fine lines/wrinkles, under-eye dark circles, and pigmentation and also improving the overall skin condition as evidenced by dermatological, instrumental, and subjective assessments on day 25, day 50, and day 75. Regular consumption of gummies significantly reduced the appearance and severity of coarse wrinkling/lines and fine lines/wrinkles, improved skin laxity, reduced skin dryness by moisturizing the skin, lighten the pigmented area and under-eye dark circles by reducing the melanin concentration, increased the radiance/glow of the skin, improved the texture and firmness of the skin, reduced skin roughness, and also improved skin tone evenness. Moreover, no adverse event was recorded during the study conduction. Conclusion: The results of this clinical study suggest that consumption of two gummies together once daily for 75 days significantly improved skin radiance/glow, skin laxity, skin hydration, skin texture and firmness, skin tone evenness and reduced skin roughness, hence improving the overall skin condition. It was found to be efficacious in reducing the appearance and severity of coarse wrinkling/lines, fine lines/wrinkles, hyperpigmentary spots, and under-eye dark circles by reducing the melanin concentration as assessed by dermatologist, various instruments, and subjective assessment. The test product also proved to be safe based on no apparent or experienced discomfort, reactions or any kind of intolerance or adverse skin reactions or events during the trial.

Publisher

Scientific Scholar

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