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
between baseline and week 8 in the active group in both face and neck, whereas there was no change in the placebo group. In terms of skin quality, there was statistically significant improvement in subject rated ‘Rough Texture’ from baseline to week 8 (P=0.01) and ‘Dryness’ (P=0.02) for the face. No statistically significant changes were found in subject rated skin quality and photodamage assessments of the neck from baseline to week 8. Seventy-one (71%) of subjects were moderately/very satisfied with the product scent, 64% with the product feel, and 71% with the product texture. Over half the subjects (57%) reported that they would consider substituting their current anti-aging skincare with Nimni cream.Adverse Events and TolerabilityNo adverse events or unexpected side effects were observed or reported for any of the subjects. No significant tolerability events were reported by investigator for face or neck (Table 2). Subjects reported minimal tolerability events for face and neck at all time points post baseline (Table 3).
New generation topical agents are continuously developed to effectively prevent photoaging, collagen degradation and, stimulate cellular epidermal/dermal remodeling that ultimately improves skin quality. The patented formulation of the study product contains a mixture of peptides, antioxidants designed to stimulate the dermal matrix for collagen and proteoglycan production. In this single-center, double-blind, randomized, placebo-controlled study Hydropeptide Nimni Cream and supporting regimen was shown to be significantly effective in improving signs of aging and skin quality in the face, with no side effects, after two months of treatment. While shown effective in the facial area, there were no significant clinical results observed in the neck area. This can be attributed to several factors; while the neck shares most of the skin physiology wit the face, it has some unique characteristics that can interfere with the efficacy of topical agents. Neck skin is inherently drier, due to the sparse sebaceous gland density, and thinner making it more susceptible to aging.13 It is possible that a longer duration of application and potentially an increased amount of product would be required in order to observe clinically significant results in this area, compared to the parameters used for the face.Moreover, Fitzpatrick Wrinkle Scale scores were improved in the active group compared to placebo, in the face and neck, albeit not significantly. While the product can have a clinical effect on skin quality rather rapidly (4-8 weeks of application), the study timeframe was too abbreviated to allow a realistic evaluation of the treatment effect on the appearance of wrinkles. With the exception of dermal fillers that can immediately volumize the face, and have a dramatic effect on wrinkles, most other anti-wrinkle approaches (energy-based devices, chemical peels), can clinically affect the appearance of lines and wrinkles after a minimum of twelve weeks. Subject satisfaction was also high as the product was easy to use with no adverse effects or tolerability issues reported.