Single-Center, Double-Blind, Randomized, Placebo-Controlled, Study of the Efficacy and Safety of a Cream Formulation for Improving Facial Wrinkles and Skin Quality

June 2018 | Volume 17 | Issue 6 | Original Article | 664 | Copyright © 2018

Neil Sadick MD,a,b Krista Bohnert BS,b Monica Serra,b and Neal Kitchen PhDc

aWeill Cornell Medical College, Cornell University, New York, NY bSadick Dermatology and Research, New York, NY cHydroPeptide LLC, Issaquah, WA

Abstract

INTRODUCTION: Several therapeutic modalities from topicals to chemical peels and energy-based devices are available to improve skin quality and reduce the appearance of wrinkles in the face and neck area. OBJECTIVE: The objective of this single-center, double blinded, placebo-controlled study was to evaluate the safety and efficacy of Nimni Cream by Hydropeptide® on skin quality and wrinkles. METHODS: 20 patients were randomized in a 3:1 ratio to use either Nimni Cream by Hydropeptide or placebo starting with twice a week application and increasing to daily for 8 weeks. Patient and investigator assessments were conducted on week 4 and 8. RESULTS: At week 8, blinded and treating investigator assessments showed a statistically significant improvement in global aesthetic improvement scale assessments in the active group for the face, but not the neck area. There was also a trend towards improvement in Fitzpatrick Wrinkle Scale scores in the active, but not placebo group, at both time-points, for the face and neck, but the results were not statistically significant. The majority of patients were satisfied with the results and no adverse effects were reported. CONCLUSION: Nimni Cream by Hydropeptide is safe and effective for improving skin quality in the face and can be considered a satisfactory therapeutic option adjuvant to aesthetic procedures. J Drugs Dermatol. 2018;17(6):664-669.

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INTRODUCTION

Over time, extrinsic and intrinsic factors indiscriminately contribute to aging of the skin. Excess exposure to UV, lifestyle choices such as smoking and alcohol, genetics, concomitant medical conditions, all together influence and aggravate the rate of degradation of skin quality.1-3 Age-dependent collagen/elastin break down, loss of hyaluronic acid (HA), epidermal thinning together with a decrease in the amount of water held in the epidermis leads to fine lines, discoloration, dullness, textural changes and wrinkles.4,5Conversely, several therapeutic modalities have been developed over time to prevent and reverse the signs of aging primarily in the facial area, but also in the neck, as it has been recognized as an extension of the facial skin that greatly impacts the overall appearance of an individual. 6. From sunscreens to sophisticated energy-based devices such as intense-pulsed-light, fractional lasers, new generation peels, there is a plethora of cosmetic solutions for improving skin quality and reducing wrinkles. Admittedly however, the use of a topical that can have these benefits would be preferred and embraced by patients as the cost-effectiveness compared to other modalities, and ease of use would reign 7-9.Over the past decade, topical anti-aging compounds have increased in number, variety, and efficacy in tackling signs of facial and neck aging. Nimni Cream by Hydropeptide® is a patented formulation created by Dr. Marcel Nimni for topical application designed to enhance collagen and proteoglycan synthesis comprising in the skin. The product ingredients include an antioxidant compound selected from the group consisting of lipoic acid, bioflavonoids, constituents of ginkgo, and isoflavones, soluble in an organic penetrant, and in a quantity sufficient to enhance collagen synthesis in the skin 10,11. Nimni cream also contains a mixture of essential amino acids comprising: isoleucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, histidine, and arginine in a topical pharmaceutically acceptable carrier. This proprietary combination of ingredients crosses the skin barrier by a patented trans-phase delivery system. In in vitro studies, the product was shown to increase deposition of collagen in the dermis and thicken the epidermal layer of rat skin.12 Moreover, when tested in human volunteers the product was well tolerated and led to results similar to the in vitro findings.The objective of this preliminary study was to evaluate the efficacy of Nimni Cream by Hydropeptide on skin quality of healthy

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