Efficacy and Tolerance of an Injectable Medical Device Containing Hyaluronic Acid and Amino acids: A Monocentric Six-Month Open-Label Evaluation
Journal Title: UNKNOWN - Year 2017, Vol 7, Issue 4
Abstract
Background: An innovative injectable solution containing low molecular hyaluronic acid (HA) and a specific Amino Acids mixture was formulated to physiologically promote local neo-collagenesis and elastogenesis through fibroblasts chemotaxis migration into the injected area. Objective: Aim of this open clinical trial is to evaluate efficacy and tolerance of the injectable product under study, on main sign of face skin photoaging. Methods: A single Italian center treated 25 female subjects aged 48-65 years with 4 micro-injection sessions with 10-day time laps between each product administration. Subjects were evaluated in basal conditions and after 4, 8, 12 and 24 weeks, using validated clinical scales, subjective evaluations and objective quantitative outcome measures. Assessment of aesthetic results included photographic documentation. Results: Obtained results showed an improvement of all the clinical and subjective assessments and on the majority of objective instrumental parameters. These were already significant 10 days after the first injection procedure and were still significant and still improving after 6 months (at follow up). Global judgment on tolerability was good/excellent, both in the investigators’ opinion and volunteers’ self-evaluation. Conclusions: Obtained results confirm the aesthetic performance of the injectable product on main signs of face skin photoaging. In particular, it was demonstrated the biovolumetric effect, the antiwrinkle efficacy, a superficial and deep moisturising activity and elasticizing properties. This study supports the definition of extracellular matrix targeting (ECM-targeting) for this product.
Authors and Affiliations
Sparavigna A, Orlandini A
Keywords
Related Articles
- EP ID EP386698
- DOI 10.4172/2167-0870.1000316
- Views 55
- Downloads 0
Toward a Comprehensive and Accurate Measure of Clinical Trial Workload, Equity, Quality Assurance and Patient Safety-How Much Workload is Too Much? Commentary and Brief Research Report
This article provides a brief commentary on the methodology surrounding controlled clinical trials, the growing trend of centers conducting multiple controlled trials (i.e. “factory science”), trial workload measures, an...
Feasibility Study of Bolus 5-Fluorouracil+L-Leucovorin as Salvage Line Chemotherapy for Oral Fluorouracil-Resistant Unresectable Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group Study HGCSG1502
In November 2015 we began a feasibility study of salvage line chemotherapy with 5-fluorouracil and l-leucovorin given in an intravenous bolus once weekly followed by a 2-week rest period within a 8-week cycle in patients...
The ANQueSt (Asian Nurse Quality of life Study) to Compare Quality of Life and Identify Related Variables: Study Protocol for a Cross-Sectional Design
Background: Hospital-based nurses’ quality of life is affected by stress coping ability, job satisfaction, job stress, and social support. These relationships appear to be identical, even among different countries. Never...
Effectiveness of Moxibustion Combined with Conventional Treatment for Moderate-Severe Persistent Allergic Rhinitis: Protocol for a Randomized, Controlled Trial
Introduction: The incidence of allergic rhinitis (AR) has risen dramatically in recent years, and presents with higher symptom frequency, affecting quality of life. Clinical research shows that conventional medical treat...
Erythroderma Due to the Association of Pegylated Interferon Alpha-2a and Ribavirin
The dermatological adverse effects due to the association of interferon Alpha and ribavirin in patients treated for hepatitis C are becoming more frequent but little is known about them. Such adverse effects range from e...