Journal of Clinical and Aesthetic Dermatology

DEC 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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15 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY December 2017 • Volume 10 • Number 12 O R I G I N A L R E S E A R C H daily in subjects presenting with mild- to-severe periocular lines, HA 5 provided both immediate and long-term significant improvements in wrinkle appearance and tactile roughness assessments as well as hydration instrumentation measurements. 8 In-vitro testing with HA 5 demonstrated enhanced expression of key markers for skin barrier function and associated increases in hyaluronic acid production. 8 Combination therapies utilizing different treatment modalities have been shown to optimize clinical outcomes for skin rejuvenation and patient satisfaction. 9–13 In this clinical study, we chose to combine HA 5 's instant and long- term effects on fine lines and wrinkles, texture, and skin hydration with the established effects of a pre-elected neuromodulator injection to assess if the combination treatment enhances overall skin quality outcomes and achieves high patient satisfaction. Our aim was to assess the effects on overall facial skin quality and patient satisfaction when combining topical treatment with HA 5 to the entire face following a pre- elected neuromodulator injection treatment to the lateral canthal areas. MATERIALS AND METHODS The immediate and long-term clinical effects of HA 5 when combined with a pre-elected neuromodulator injection procedure were evaluated in an open-label, single-center clinical study in subjects presenting with moderate-to-severe periocular (i.e., under- eye) wrinkles. Subjects were neuromodulator injection-experienced, defined as having received at least two neuromodulator injection procedures to the lateral canthal area within the last 18 months. Twenty healthy female subjects aged 18 years to 65 years old were eligible to enroll in the eight-week study. All subjects were required to present with mild-to-severe periocular lines or wrinkles, as determined by a grade of 4 to 9 on the investigator's periocular fine lines and wrinkles scale based on the modified 10-point Griffith's scale. 14 Subjects were allowed continued use of their regular facial cosmetic products during the study, with regular use defined as products used for a minimum of three months prior to enrollment without any incidence of irritation. Institutional review board approval from the Chesapeake Institutional Review Board and informed consent was obtained from subjects prior to commencement of any study procedures. This study was conducted according to ethical and regulatory principles for the protection of human subjects for research as outlined in 21 CFR 50, in accordance with the accepted standards for Good Clinical Practice (GCP) and the International Conference on Harmonization (ICH). Photoconsent from study subjects was also received. The study was conducted in San Diego, California, from September 2015 to February 2016. At the baseline visit, clinical assessments and standardized digital photography (Canfield Vectra; Canfield Imaging Systems, Fairfield, New Jersey) of the subjects' clean facial skin were conducted. Subjects then received a pre-elected neuromodulator injection in the left and right lateral canthal areas. After the procedure, HA 5 was applied to the entire face, including the lateral canthal areas. Clinical assessments and standardized photography were conducted again to capture immediate effects 15 minutes post-procedure. Subjects were instructed to apply a thin layer of the HA 5 formulation (e.g., a nickel-sized amount) to their entire face twice daily (morning and evening) after cleansing for eight weeks. At Weeks 2, 4, and 8, subjects returned to the study site for clinical assessments and photography, after washing their face with a cleanser and water. Subjects also completed a questionnaire regarding self-perceived skin quality from the treatment combination and were asked to compare their current experience to past injection procedure experiences. Clinical efficacy of the HA 5 formulation was assessed by the investigator at baseline (pre- neuromodulator injection and HA 5 application); baseline again (post-neuromodulator injection and HA 5 application); and at Weeks 2, 4, and 8 using the following grading scales: Facial Wrinkle Scale (FWS) with Photonumeric Guide (lateral canthal area); Fine Lines/Wrinkles in the periocular-under eye, periocular-lateral canthal area, forehead area, cheek areas, and perioral area; and Tactile Roughness (full face). The assessments are described in detail in Table 1. Safety and tolerability of the product was assessed through the capture of adverse events. Mean clinical grading scores (investigator assessments) at baseline (post-treatment) and at Weeks 2, 4, and 8 were compared with baseline scores (pre-treatment) using a Student's paired t-test. Statistical differences were considered significant at the p<0.05 level. Analysis was conducted on the intent-to-treat TABLE 1. Assessment scales GRADING SCALE DESCRIPTION FACIAL AREA Facial Wrinkle Scale • None (0) • Mile (1) • Moderate (2) • Severe (3) • Periocular-lateral canthal area Fine Lines/Wrin- kles Scale • None (0): no fine lines/wrinkles present; skin looks completely smooth and wrinkle-free • Mild (1–3): rare, presence of fine lines and wrinkles that are widely spaced apart in the treatment area • Moderate (4–6): moderate number of fine lines/wrinkles in close proximity to each other in the treatment area • Severe (7–9): many fine lines/wrinkles densely packed together in the treatment area • Periocular-under eye • Periocular-lateral canthal area • Forehead • Cheeks • Perioral Tactile Roughness Scale • None (0): no roughness of the treatment area; skin is completely smooth and pliable • Mild (1–3): some areas of slightly irregular roughness in the treatment area • Moderate (4–6): several areas of definite roughness of the treatment area • Severe (7–9): marked roughness of the treatment area associated with a stiff feeling • Entire face

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