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
candidates with moderate to severe facial wrinkles and folds. As skin quality is multifactorial assessments included live investigator ratings, patient questionnaires and ratings of standardized photographs by a qualified evaluator not in involved in patient treatment and blinded to photographic time points. The tolerability, and safety of Nimni Cream by Hydropeptide was also evaluated.
Patients20 subjects were enrolled in the study. All subjects provided written informed consent prior to receiving any study-related procedures. Patients were screened according to the inclusion/exclusion criteria of the study and participant eligibility was determined. Eligible subjects were healthy females (30-70 years of age, Fitzpatrick photo skin types I-IV), with moderate to severe fine lines, wrinkles, and overall skin quality as determined by the investigator. Subjects were required to avoid sun-exposure in the treated areas, and not have any procedures affecting facial wrinkles or skin quality (ex. microdermabrasion, peels, acne treatments, filler, botulinum toxin, radiofrequency, laser, IPL, ultrasound, etc) for the duration of the study. Patients that had cosmetic treatments (botulinum toxin, fillers, peels, lasers, dermabrasion) within 3 months of the baseline visit were excluded. Subjects with dermatologic conditions including acne, rosacea, eczema, psoriasis, actinic keratosis, severe sun damage, scars, or a history of keloids were also excluded from the study.Study DesignThis was a single-center, double-blind, randomized, placebo-controlled, study conducted in accordance with the principles of the Declaration of Helsinki, current GCP guidelines, and IRB approval. A total of 20 patients were randomized in a 3:1 ratio to use either Nimni Cream by Hydropeptide or placebo as instructed by protocol. Treatment consisted of topical application to facial and neck skin at increasing frequency beginning with application two times per week before bed and increasing to once daily application by week 8 based on tolerability. All subjects were also provided with an identical regimen of homecare products (Facial Cleanser (am/pm), Sunscreen (am), and Moisturizer (PRN)). Live efficacy assessments were conducted at weeks 4 and 8 by both subject and investigator, with a blinded investigator assessment completed at week 8 using subject photos collected at baseline. Visual assessments of the face were conducted on all subjects grading for fine lines, wrinkles, mottled pigmentation, pore size, clarity/radiance, laxity, and overall global photodamage at each visit by a live qualified investigator. Safety and tolerability assessments included an evaluation of erythema, peeling, dryness, and roughness by both subject and investigator. Subject assessment (patient reported outcomes or PROs) of product attributes and impression of efficacy were also collected at each visit. Standardized photos were taken at in office visits occurring at baseline (D0), week 4, and 8. The primary endpoint was defined as the degree of improvement in skin quality rated by a blinded, trained evaluator using standardized photographs, as well as live evaluations by the treating investigator and the patient reported outcome assessments. Secondary endpoints included the positive investigator and patient satisfaction assessed with quartile scales, the efficacy for the correction of moderate to severe facial wrinkles and folds with Validated Assessment Scales (VAS), the