Dataset Information

VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study.

ABSTRACT: Objective:Evaluate safety and effectiveness of VYC-12 (Juvéderm Volite; an injectable crosslinked hyaluronic acid gel designed to improve skin quality attributes such as surface smoothness and hydration) for facial intradermal injection. Materials and methods:In a prospective, single-arm study, subjects with moderate/severe cheek skin roughness per Allergan Skin Roughness Scale (ASRS) received VYC-12 in the cheeks and forehead, and/or neck, with touch-up treatment to correct asymmetry 30 days later and optional repeat treatment 9 months after last treatment. The primary effectiveness measure was ASRS responder rate (percentage of cheeks with ?1-point improvement from baseline) at month 1. Skin hydration was instrument-assessed. Results:Of 131 subjects treated, 31 (23.7%) received touch-up treatment. ASRS responder rate was 96.2% at month 1, 76.3% at month 4, 34.9% at month 6, and 87.1% after repeat treatment. Responder rate in cheeks with severe baseline roughness was 93.8%, 83.1%, and 52.3% at months 1, 4, and 6, respectively. Skin hydration improved significantly (P<0.01) from baseline at all timepoints through month 9. Injection site responses were as expected. All treatment-related adverse events were mild/moderate. Conclusion:VYC-12 safely and effectively improved skin smoothness up to 6 months and hydration lasting 9 months.

SUBMITTER: Niforos F

PROVIDER: S-EPMC6817835 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study.

Niforos François F Ogilvie Patricia P Cavallini Maurizio M Leys Christophe C Chantrey Jonquille J Safa Marva M Abrams Steve S Hopfinger René R Marx Ann A

Clinical, cosmetic and investigational dermatology 20191024

<h4>Objective</h4>Evaluate safety and effectiveness of VYC-12 (Juvéderm Volite; an injectable crosslinked hyaluronic acid gel designed to improve skin quality attributes such as surface smoothness and hydration) for facial intradermal injection.<h4>Materials and methods</h4>In a prospective, single-arm study, subjects with moderate/severe cheek skin roughness per Allergan Skin Roughness Scale (ASRS) received VYC-12 in the cheeks and forehead, and/or neck, with touch-up treatment to correct asymm ...[more]

PMID: 31749628

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Project description:ObjectivesTo determine the effect of skin-to-skin care on stress, pain, behavioral organization, and physiologic stability of infants with critical congenital heart disease before and after neonatal cardiac surgery.DesignA baseline response-paired design was used, with infants acting as their own controls before, during, and after skin-to-skin care at two distinct time points: once in the preoperative period (T1) and once in the postoperative period (T2).SettingCardiac ICU and step-down unit in a large metropolitan freestanding children's hospital.SubjectsConvenience sample of 30 infants admitted preoperatively for critical congenital heart disease.InterventionsEligible infants were placed into skin-to-skin care for 1 hour with their biological mothers once each at T1 and T2.Measurements and main resultsMeasurements of stress (salivary cortisol), pain and behavior state (COMFORT scale), and physiologic stability (vital signs) were assessed immediately before skin-to-skin care, 30 minutes into skin-to-skin care, and 30 minutes after skin-to-skin care ended.At both T1 and T2, infant pain scores were significantly decreased (p < 0.0001) and infants moved into a calmer behavior state (p < 0.0001) during skin-to-skin care as compared to baseline. At T1, infants also had significantly reduced heart rate (p = 0.002) and respiratory rate (p < 0.0001) and increased systolic blood pressure (p = 0.033) during skin-to-skin care. At both T1 and T2, infant cortisol remained stable and unchanged from pre-skin-to-skin care to during skin-to-skin care (p = 0.096 and p = 0.356, respectively), and significantly increased from during skin-to-skin care to post-skin-to-skin care (p = 0.001 and p = 0.023, respectively). Exploratory analysis revealed differences in cortisol reactivity for infants with higher baseline cortisol (> 0.3 μg/dL) versus lower (≤ 0.3 μg/dL) prior to skin-to-skin care. Infants with higher baseline cortisol at T2 experienced significantly reduced cortisol during skin-to-skin care (p = 0.025). No significant differences in demographics or baseline variables were found between infants in either group.ConclusionsSkin-to-skin care is a low-cost, low-risk intervention that promotes comfort and supports physiologic stability in infants before and after neonatal cardiac surgery.

Dataset Information

VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study.

Publications

VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study.

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