Search

OBJECTIVE: The aim of the present study was to assess the safety and efficacy of Diclofenac sodium (DS) 140 mg medicated plaster vs. Diclofenac epolamine (DIEP) 180 mg medicated plaster and placebo plaster, for the treatment of painful disease due to traumatic events of the limbs. PATIENTS AND METHODS: This was a multicenter, phase III study involving 214 patients, aged 18-65 years, affected by painful conditions due to soft tissue injuries. Patients were randomized to DS, DIEP or placebo arms and treated with once-daily application of the plaster for a total treatment period of 7 days. The primary objective was first to demonstrate the non-inferior efficacy of the DS treatment when compared to the reference DIEP treatment and second that both, test and reference treatments, were superior with respect to placebo. The secondary objectives included the evaluation of efficacy, adhesion, safety, and local tolerability of DS in comparison to both DIEP and placebo. RESULTS: The mean visual analog scale (VAS) score decrease for pain at rest was higher in the DS (-17.65 mm) and the DIEP group (-17.5 mm) than in the placebo (-11.3 mm). Both active formulation plasters were associated with a statistically significant pain reduction compared to placebo. No statistically significant differences were observed between DIEP and DS plasters efficacy in relieving pain. Secondary endpoint evaluations supported the primary efficacy results. No serious adverse events (SAEs) were registered, and the most commonly detected adverse events were skin reactions at the application site. CONCLUSIONS: The results showed that both the DS 140 mg plaster and the reference DIEP 180 mg plaster are effective in relieving pain and present a good safety profile. [ABSTRACT FROM AUTHOR]

OBJECTIVE: In this premarket clinical study, we evaluated the efficacy and safety of a novel Hydrogel (HYADD4-G) for reducing low back pain (LBP) in patients with degenerative disc disease (DDD). PATIENTS AND METHODS: Twenty-three patients with chronic LBP were enrolled. All patients presented with up to three lumbar black discs (Pfirrmann grade III or IV), LBP of at least 40 mm on the Visual Analogue Scale (VAS), and a Roland--Morris Disability Questionnaire (RMDQ) score of at least 9. Patients received a single 1.5 ml intradiscal injection of HYADD4-G (8 mg/ml), guided by X-ray. Our primary endpoint was the change in VAS score from baseline (day 0) to 4, 12, and 24 weeks. Our secondary endpoints were black disc hydration by Magnetic Resonance Imaging (MRI); the patient's therapeutic response according to the RMDQ; the quality of life, as determined by the EuroQol-5 Dimension (EQ-5D) Index; and a global assessment of patient health status, safety, and local tolerability. RESULTS: Compared with baseline values, VAS score showed a significant reduction at each time point, and across the overall 24-week follow-up period (p < 0.0001). MRI scanning observed a significant reduction in Pfirrmann grade from baseline, by at least one grade, at both week 4 (p = 0.0039) and week 24 (p = 0.0010). Furthermore, compared with baseline values, there was a significant reduction in RMDQ score at each timepoint, and across the entire study period (p < 0.0001). The EQ-5D index increased significantly from baseline to week 24 (p = 0.0001). Finally, mean VAS scores for Patient Global Assessment (PTGA), and Clinical Observer Global Assessment (COGA), decreased significantly at each time point (p < 0.0001), except for week 4. CONCLUSIONS: HYADD4-G proved to be an efficient reliever of low back pain due to DDD. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The aim of this study is to evaluate the efficacy and safety of a new ointment containing Hyaluronic Acid and collagenase from non-pathogenic Vibrio alginolyticus. PATIENTS AND METHODS: Double blind, multicenter, controlled clinical trial (no. ISRCTN71239043) conducted to demonstrate the superiority of Hyaluronic Acid-Collagenase applied once a day over placebo in mean reduction of devitalized/fibrinous/slough tissue after 15 days of treatment. 113 patients with venous ulcers were enrolled and randomized to receive active treatment therapy or vehicle preparation. Both arms also received compression therapy. Subjects were assessed at baseline and at 4 different clinical study visits up to a maximum of 30 days. Outcome measures included mean percentage debridement evaluated by digital planimetry, pain during change of dressing measured on a visual analogue scale and adverse event assessment for tolerance. RESULTS: After 15 days the debridement rate in the active group was 67.5% compared to 59% in the placebo group (p = 0.0436). A significantly higher number of patients in the treatment group achieved 100% debridement by day 15 (p = 0.0025) than in the control group, and a higher percentage also demonstrated complete debridement at every other time point. Pain perception was similar in both groups with low levels during medication. No differences in tolerance were observed between groups. CONCLUSIONS: Chronic venous ulcers treated with this novel compound of Hyaluronic Acid and collagenase resulted in a significantly higher debridement rate at Day 15 vs. the control group. Hyaluronic Acid-Collagenase was well tolerated and a low degree of pain was perceived during dressing change. The preparation of 0.2% of Hyaluronic acid-collagenase shows significant benefits in the management of chronic ulcers. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To evaluate the longterm efficacy and safety of Hymovis® in the symptomatic treatment of knee osteoarthritis (OA). PATIENTS AND METHODS: This is a prospective, multi-center, open label, phase III clinical study. Two intra-articular injections (3 mL) of Hymovis ® (8 mg/mL HYADD® 4) were administered 1 week apart at the beginning of the study on day 0 and day 7 and after 6 months from baseline, on day 182 and 189. Follow-up assessment were conducted for 52 weeks. 50 subjects, > 40 years old, with knee OA, with clinical and radiological confirm, complain pain in the target knee were enrolled. The variables considered were: WOMAC questionnaire, Joint Space Width (JSW), OMERACT OARSI responder criteria, EQ- 5D questionnaire, rescue medication consumption. RESULTS: A fter t he i njections of H ymovis®, pain perceived by the patient when walking on a flat surface (WOMAC A1 score) significantly improves at the end of the study respect to the baseline. WOMAC stiffness, physical function and total score significantly improve during the study since 3 months after treatment, and it is maintained up to the end of the study (p < 0.001). By the x-ray analysis of knee, a radiological progression of OA was observed in the 26% of patients at the end of the study, while 88% of patients result to be responder to the therapy classified as per OMERACT-OARSI criteria. The EQ-5D weighted index increased significantly, against baseline, at each study time point (p < 0.001). Investigator's and patient's global assessment of the disease measured by the VAS both show a marked improvement in patient's health conditions. CONCLUSIONS: R esults f rom t his s tudy confirm that Hymovis® alleviate the knee pain since the first treatment cycle. The patients treated with two cycles of intra-articular injections of Hymovis® have a progressive pain reduction that is maintained up to one year after the treatment start with improve of all the scores considered in this study. Hymovis® is effective and safe in symptomatic treatment of painful knee OA. [ABSTRACT FROM AUTHOR]

BACKGROUND: Bed debridement is important to treat chronic wounds. Effective agents should remove the necrosis but protect the granulation tissue. We evaluated the performance and tolerability of a new composite ointment containing collagenase and hyaluronic acid for chronic venous ulcers. PATIENTS AND METHODS: Subjects with class 6 venous ulcers (CEAP classification) of at least 6 months duration were prospectively recruited. The ointment was administered daily and follow-up visits were conducted on the fifth, 10th, 15th and 20th days. On each visit the necrotic area was measured with a grid. The moisture balance, odour, viability of non-necrotic areas and the presence of erythema were also assessed. Primary outcome was the percentage of subjects with complete debridement, secondary outcomes the time to complete healing, reduction of the lesion area, absence of necrotic tissue, presence of odor, erythema, hydration, any adverse events. RESULTS: One hundred subjects were enrolled in four centres. All patients achieved complete debridement of the necrotic area and a significant reduction of the total ulcer area by day 20, while other parameters improved significantly over time. Only two patients experienced a transient leg oedema. CONCLUSIONS: The combination of collagenase and hyaluronic acid is safe and effective for chronic venous ulcers. [ABSTRACT FROM AUTHOR]

Background. Achilles and patellar tendinopathies are common causes of chronic pain and functional impairment. Conservative management can be effective, but it is time-consuming and it requires intensive patient compliance. Hyaluronic acid (HA) is a key component of the extracellular matrix and its anti-inflammatory, lubricant and analgesic properties are well documented in osteoarthritis. Growing pre-clinical studies indicate a possible role of HA in tendon pathology, while clinical evidences are still lacking. Objectives. The primary objective was to assess the efficacy of a new formulation of HA obtained from biofermentation (Hyalotend® Fidia Farmaceutici, Italy) to improve the clinical symptoms assessed by the VISA-A and VISA-P questionnaires at 90 Days of follow-up. Secondary objectives were to evaluate improvement in pain (NRS-11), US parameters (tendon appearance and neovascularization), and quality of life (EQ-5D). Safety was also evaluated. Methods. This was a prospective, open-label, multicenter clinical trial. Thirty-five patients (26 in AT group; 9 patients in PT group), who satisfied inclusion and exclusion criteria, were recruited during a 4-month period. Each patient received 1 injection weekly for 3 weeks under US-guidance at the painful site, and was evaluated at 14, 45 and 90 days after the procedure. Subjects were instructed to record on a diary any intakes of the permitted rescue medication for pain relief oral paracetamol, up to the "rescue dose" of 3 g/Day (i.e. 6 tablets/Day) throughout the study period and to interrupt treatment at least 24 hours prior to each visit. Results. Significant improvement occurred in both VISA-A (23.22±23.17; 95% CI: 13.20; 33.24; p<.0001) and VISA-P (19.25±11.61; 95% CI: 9.54; 28.96; p=0.0022). NRS-11 score significantly decreased in subjects with AT or PT during the study (p<0.0001 and p=0.0040 respectively). Significant improvement of swelling and tenderness evaluated with US in the AT group was revealed (McNemar's test; p=0.0016 and p=0.0114, respectively), while in the PT group the presence of these clinical symptoms showed only a non-significant tendency to decrease (p=0.3173 for both). The EQ-5D-5L total score increased in both the AT and PT groups (mean change vs. baseline at day 90 equal to 15.96±18.95 (range: -50; 45) and 15.50±32.42 (range: -40; 71), respectively. Seven patients (20.59%) experienced at least one adverse event (AE), all AEs had mild severity. No serious AE or other significant AE leading to study treatment discontinuation or temporary interruption was reported. Conclusions. Three US-guided HA injections may induce prompt improvement in pain and function in mid-portion Achilles and patellar tendinopathies that last until 90 days of followup. Amelioration in tendon structure, neovascolarization and clinical parameters may also be achieved. The treatment is also safe and well-tolerated. [ABSTRACT FROM AUTHOR]

Background: The study aimed to assess the performance and safety of single-use applicators prefilled with hyaluronic acid (HA)-based vaginal gel (Hyalo Gyn) for the treatment of vulvovaginal atrophy (VVA)-related signs and symptoms in postmenopausal women., Methods: Eighty women were randomized, 46 to Hyalo Gyn gel and 34 to a standard treatment (water-based lubricant). Outcome data collected included: the proportion of subjects having a reduction ≥1 point in the Verbal Rating Scale (VRS) Dryness Score, VRS Global Score, vaginal pH, Vaginal Health Index, Female Sexual Function Index, Female Sexual Distress Scale-Revised, patients' global assessment, tolerability, and safety., Results: Significant improvements were observed for all the assessed endpoints in both treatment groups. The perception of any improvement on the VRS Dryness Score was not statistically different between the treatment groups. A sensitivity analysis on the absolute change in VRS Dryness Score showed a statistically significant difference in favor of the Hyalo Gyn group at 3 months., Conclusions: A 3-month treatment with Hyalo Gyn gel is effective, safe, and well tolerated for VVA-related symptoms in postmenopausal women.

Viscosupplementation by hyaluronic acid (HA) is recommended for non-surgical management of knee osteoarthritis (OA). This study investigated the efficacy and safety of a single i.a. (32 mg/4 ml) Hymovis MO.RE. injection, a new HA derivative hydrogel, for the treatment of adult regular sports players affected by knee OA arising from overuse injuries. Patients were prospectively enrolled if regularly practicing sports and diagnosed with Kellgren-Lawrence grade I-III OA. They received a single Hymovis MO.RE. intra-articular (i.a.) injection and were evaluated 30, 90, 180, and 360 days thereafter. The assessment involved measuring changes in knee function, pain, the activity of daily living (ADL), and quality of life (QOL) by using the Knee injury and Osteoarthritis Outcome Score (KOOS), GAIT analysis, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores for knee pain (WOMAC A) and function (WOMAC C), and a visual analogue scale (VAS) pain score. The study involved thirty-one patients, 23 women and eight men, whose median age was 49. KOOS function subscore, as well as GAIT cadence and velocity, showed a statistically significant increase at each time-point after injection ( p < 0.0001). WOMAC, KOOS pain, symptoms, ADL, and QOL scores also significantly improved at all control visits. No severe adverse events or treatment-related events were detected. A single Hymovis MO.RE. (32 mg/4 ml) intra-articular injection provides a rapid, lasting, and safe response in regular sports players affected by knee OA, possibly representing a viable therapeutic option for this demanding patient subgroup. Further investigations are necessary to confirm these findings., Competing Interests: NG is an employee of Fidia Farmaceutici SpA. (Abano Terme, PD, Italy). However, Fidia Farmaceutici SpA did not participate in the decision to submit this manuscript for publication. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Bernetti, Agostini, Alviti, Giordan, Martella, Santilli, Paoloni and Mangone.)

Background: The reduced concentration of hyaluronic acid in the synovial fluid, leading to impairment of joint function and painful symptomatology during knee osteoarthritis (OA), can be restored by using injectable formulations of hyaluronic acid (HA) and chondroitin sulfate (CS), variable for relative composition, HA/CS molecular modifications, and injection protocols. The present study aims to assess the safety and performance of the intra-articular (IA) viscosupplementing agent HYALGO, a formulation combining 40 mg/mL HA (>1700 kDa) and 40 mg/mL CS, in the treatment of patients suffering from knee OA., Methods: 74 patients affected by knee lesions classified as grade II and III according to Kellgren and Lawrence classification were prospectively recruited and treated with three HYALGO injections (2 mL) given one week apart. Visual analogue scale (VAS) pain changes were monitored at each injection and over-time at 6, 14, and 26 weeks of follow-up. Secondary endpoints were: Western Ontario McMaster University Osteoarthritis index (WOMAC), Patient's Global Assessment (PGA) score, Clinical Observer Global Assessment (COGA) score, Outcome Measures in Rheumatology Committee (OMERACT) and Osteoarthritis Research Society International (OARSI) responders rates. Patients were also assessed for changes in their ultrasound joint scores according to the criteria of the OMERACT US Task Force Group., Results: Pain reduction was statistically significant starting from the first IA injection. Mean pain reduction from baseline to week 26 was -90.6%. At 26 weeks, WOMAC Pain was reduced by -62.7%, WOMAC Stiffness by -47.2%, WOMAC Physical Function by -54.1%; Total WOMAC by -53.8%. The VAS PGA change from baseline was -48.0 [mm] and VAS COGA -41.0 [mm]. Responders at week 26 were 78.4%. Ultrasound parameters (joint effusion, synovial thickness, and popliteal cysts) improved or remained stable from baseline to week 6., Conclusions: Three injections of HYALGO were safe and effective to manage symptomatic knee OA, with a beneficial effect that increased progressively over time, peaking 6 months after injection., (© 2021 Delhi Orthopedic Association. All rights reserved.)

Objective: To confirm the safety and wound healing activity of a topical spray powder containing hyaluronic acid (HA) and metallic silver (Hyalosilver, Fidia Farmaceutici S.p.A., Italy), and investigate its effect on the control of bacterial load in vascular ulcers or category I-II pressure ulcers (PU)., Methods: This is a single site, prospective, open label study involving patients with a vascular ulcer or category I-II PUs, presenting signs of critical bacterial colonisation. Patients with a wound size of ≤15cm 2 were enrolled. At baseline, a swab was taken of each wound for a semi-quantitative analysis of bacterial load and the first treatment of topical spray powder was applied. The patient was then requested to self-apply the medication once a day for 28 consecutive days and to return on days one, seven and 28 for clinical and microbiological assessments., Results: A total of 25 patients were enrolled in the study. Treatment with the topical spray powder enhanced the healing rate of chronic wounds in terms of a reduction of wound area as well as bacterial load (p<0.025) and the overall clinical status of wound (odour, exudate, erythema of periwound skin; p<0.017). Moreover, the spray powder increased overall patient perception of improvement in the wound (p<0.05)., Conclusion: The data demonstrated good safety and tolerability of the topical spray powder suggesting that the product is effective not only in reducing wound area, due to the presence of HA, but in keeping the bacterial colonisation under control.

Background: The objective of this pilot study was to identify biological, clinical or structural biomarkers of an intra-articular hyaluronic acid injection efficacy (HYMOVIS®) for the design of a larger placebo-controlled clinical trial studying the disease-modifying activity of this treatment., Methods: Forty six patients with symptomatic knee Osteoarthritis (OA) were enrolled in this open-label, prospective, multicenter, pilot study. Patients received two treatment cycles of intra-articular injections (3 mL) of HYMOVIS® (8 mg/mL of hyaluronic acid hexadecylamide) at 6 months interval. Each treatment cycle involved two intra-articular injections 1 week apart. All patients had Magnetic Resonance Imaging (MRI) of the target knee at baseline and 1 year, and blood samples to assess joint biomarkers. The primary outcome was the change in type II collagen-specific biomarkers (Coll2-1, Coll2-1NO2 and CTX-II) after HYMOVIS® treatment versus baseline. Secondary endpoints included levels changes in aggrecan chondroitin sulfate 846 epitope (CS-846), Cartilage Oligomeric Matrix Protein (COMP), procollagen type II N-terminal propeptide (PIIANP), Matrix Metalloprotease (MMP)-3, Myeloperoxidase (MPO) and Interleukin (IL)-6 serum biomarkers, the ratio Coll2-1/PIIANP, CTX-II/PIIANP, variation of MRI cartilage volume, and Knee injury and Osteoarthritis Outcome Score (KOOS) index., Results: Coll2-1 serum levels significantly increased overtime while Coll2-1NO2 levels were only increased at D360. Serum PIIANP levels also progressively and significantly enhanced with time. In contrast, other serum biomarker levels including CTX-II, CS-846, COMP, MMP-3, MPO or IL-6 did not change significantly overtime. Interestingly, the ratios Coll2-1/PIIANP and CTX-II/PIIANP decreased, indicating a decrease of cartilage catabolism. Compared to baseline value, MRI cartilage volume and thickness increased in lateral femoral and lateral trochlea compartments and not in medial compartment. These results, in addition to an improvement of T2 mapping score suggest a positive structural effect of the product. Interestingly, WORMS effusion score, an indicator of synovitis, significantly decreased. Finally, global KOOS score and subscales significantly increased overtime while pain at rest, walking pain and patients or investigators global assessment of disease activity decreased. The safety profile was favorable with a low incidence of injection-site pain., Conclusion: HYMOVIS®, a well-tolerated intra-articular treatment, significantly enhanced type II collagen turnover as suggested by the increase in Coll2-1 and PIIANP levels and cartilage volume observed by MRI in lateral knee compartment. Importantly, this study provides critical information for the design of a larger phase III clinical trial investigating Disease Modifying effect of HYMOVIS®., Trial Registration: http://www.isrctn.com/ISRCTN12227846 11/02/2015.

Introduction: The current study compares two hyaluronic acid fillers, Ial System Duo and Belotero Basic/Balance, for the treatment of wrinkles., Materials and Methods: This is a single-center, double-blind randomized controlled study. Inclusion criteria consisted of subjects with bilateral nasolabial wrinkles. Each subject was treated with both products: One was applied on the right side and the other on the left side of the face. The quantity of product injected and any problems or local reactions (erythema, edema, pain or itching) were recorded and reassessed at 3 and 6 months and then monthly until complete absorption of the product. The Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS) were used for the assessment, as well as an ultrasound measurement of the skin thickness., Results: Complete data were available for 59 subjects. At 3 and 6 months, both products showed improvement in the WSRS and GAIS score in the areas treated compared to pre-treatment assessments, although no significant differences were observed between them. No resulting significant differences were observed on skin thickness among the two products, which were completely reabsorbed in 285 ± 34 days (Ial System Duo) and 277 ± 34 days (Belotero Basic/Balance; Student's t test: p = 0.2181). No significant differences were observed with regard to the subject's satisfaction and adverse events., Conclusions: The Ial System Duo achieves long-term permanence (more than 9 months confirmed by ultrasound) in correction of moderate and severe wrinkles, similar to Belotero Basic/Balance. Both products showed a high safety profile and a high degree of subject and physician satisfaction., Level of Evidence Ii: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Background: Tendinopathies are conditions characterized by activity-induced pain, local tenderness and swelling for which a gold standard treatment is not established yet. Hyaluronic Acid (HA) is a key-molecule in several cellular activities and it is normally present in the extra-cellular matrix of tendons and ligaments. Amongst its properties, HA injections may reduce pain and determine disease-modifying effects. This study is an investigator-initiated open-label trial conducted to investigate the efficacy and safety of HA (500-730 kDa) peritendinous injections on pain reduction in patients affected by lateral elbow, Achilles or patellar tendinopathy., Methods: A total of 71 tendons (34 with Achilles tendinopathy, 26 with lateral elbow tendinopathy, 11 with patellar tendinopathy) of 62 patients with painful tendinopathy were treated with a cycle of ultrasound-guided peritendinous injections one injection per week for three consecutive weeks. Efficacy assessments included changes in pain intensity measured by Visual Analogue Scale (VAS) at follow-up evaluations were performed 7 (V2), 14 (V3) and 56 days aften first treatment. An Ultrasound (US) assessment was also performed to evaluate changes in tendon thickness and neovascularization. Adverse events were recorded for safety analysis throughout the study. All results were analyzed with descriptive statistics appropriate to the nature of the variables., Results: Significant reduction in VAS (p<0.001) from baseline was observed in Achilles (-6.16 ± 0.45 cm), patellar (-6.16 ± 0.72 cm) and lateral elbow (-5.33 ± 0.43 cm) tendinopathies. The sagittal thickness decreased significantly from baseline at each endpoint (V3 day 14 and V4 day 56) in each type of tendinopathy analyzed (p<0.05). Neovascularization decreased for each tendons at V3 and V4, except for patellar tendon at V3 V1 (p=0.125). Nevertheless, reduction at V4 compared to baseline remained significant (p=0.016)., Conclusions: US-guided HA (500-730 kDa) peritendinous injections determine significant pain relief and reduction in tendon thickness and neovascularization in US evaluations. The effect of HA did not show differences regarding the site of affected tendon. The treatment proved to be safe and very well tolerated., Level of Evidence: 4., Competing Interests: Conflict of interest This study was an investigator initiated study carried out in accordance with internationally recognized standards, such as the Declaration of Helsinki and the ICH’s Guideline for Good Clinical Practice. The Authors declare that they have no conflict of commercial interest. Nicola Giordan is an employee of Fidia Farmaceutici S.p.A. All Authors state, however, that Fidia Farmaceutici S.p.A. did not solicit this research project or protocols with investigators or institutions. Fidia Farmaceutici S.p.A. was not responsible for the initiation of the study and did not participate in the scientific design of the trial, in the creation of the protocol, management of the study, data analysis, reporting and in the decision to submit the manuscript for publication.

Purpose: this study aimed to investigate the efficacy of intra-articular (IA) administration of a hydrogel formulation obtained from a hyaluronic acid (HA) derivative (HYADD4(®)) in the management of meniscal tears and in meniscal tear repair., Methods: fifty subjects with degenerative meniscal tears were enrolled into this single-site, observer-blind, parallel-group study. Clinical evaluations were performed at baseline and after 14, 30 and 60 days. Clinical outcomes included: pain reduction (Visual Analog Scale), improvement of knee functionality (WOMAC questionnaire), reduction in length and depth of the meniscal lesion (MRI-confirmed) and SF-36 questionnaire scores. Local tolerability and safety were also investigated., Results: a significant reduction in VAS pain (p< 0.001) in favor of HYADD4(®) was recorded at day 14 and maintained at all the follow-up assessments. Data on knee functionality were in line with the VAS pain assessment results. A significant reduction in length and depth of the meniscal lesion, assessed using MRI, was found in the HYADD4(®) group compared to the control group (p<0.001)., Conclusions: the results of this study may indicate a new treatment option in the conservative management of patients complaining of pain due to meniscal tears. The MRI data suggest that the hydrogel formulation of HA used in this study may also play a role in the healing process of the lesion., Level of Evidence: Level I, prospective randomized clinical trial.

Purpose: numerous experimental and clinical studies in osteoarthritis (OA) have demonstrated that intra-articular (IA) administration of hyaluronic acid can improve the altered rheological properties of the synovial fluid and exert protective and reparative effects on the joint structure. The objective of this study was to evaluate the safety and performance of HYADD®4-G (Hymovis®) in patients with glenohumeral joint OA., Methods: forty-one patients with shoulder pain and limited shoulder function resulting from concentric glenohumeral joint OA were enrolled in a multicenter clinical trial. Patients received two HYADD®4-G injections administered one week apart. The main outcome measure was improvement in shoulder pain on movement at six months as assessed through a 100-mm visual analog scale (VAS), range of motion (ROM) values, and Constant-Murley Shoulder Outcome Score (CS)., Results: two IA injections of HYADD®4-G (Hymovis®) significantly decreased pain and improved shoulder function for up to six months from the first injection. The VAS score decreased (from 66.1 mm to 37.7 mm at six months) and improvements were recorded in the total CS and in the ROM values ( rotation decreased from a mean value of 54.2° at baseline to 63.2° at six months and internal rotation from a mean value of 44.0° at baseline to 45.7° at 26 weeks). No serious adverse events occurred., Conclusions: the study results demonstrated that two IA injections of HYADD®4-G (Hymovis®) may be a safe and effective treatment option for shoulder pain associated with glenohumeral OA and that the effects of the injections are still present for up to six months after the treatment., Level of Evidence: Level IV, therapeutic case series.

Background: This study aimed to assess the efficacy and the safety of a newly-developed patch containing diclofenac sodium 140 mg in patients affected by acute soft tissue sport injuries, such as contusion, strain and sprain with a randomised, double-blind, placebo-controlled trial., Methods: One hundred and sixty-four subjects were recruited within 3 hours of a soft-tissue sport injury and were equally assigned to receive diclofenac or placebo patch applied twice a day for 7 days. The primary study endpoint was reduction in severity of pain on movement from baseline to 48 hours measured by Visual Analogue Scale. Secondary outcomes were reduction of pain on movement and at rest, reduction of pain on pressure, time to efficacy onset, global efficacy assessment and use of rescue analgesics., Results: The reduction of pain on movement from baseline to day 2 was markedly greater in the diclofenac group compared with placebo (treatment effect: -24.25 mm, P<0.001 between groups). Statistically significant improvements were also observed in the diclofenac group compared to placebo for the secondary variables of pain on movement and at rest, pain on pressure, time to efficacy onset and global patient and investigator efficacy assessment. Local adverse reactions at the application site were reported in comparable rates in the two groups., Conclusions: The diclofenac patch could be a safe and effective alternative to the oral administration of non-steroidal anti-inflammatory drugs in the treatment of minor sport injuries.

Objectives: The present study aimed to evaluate the effectiveness and safety of hyaluronic acid gel for the treatment of volume loss or contour deficiency., Methods: This 6-month, open-label study recruited sixty adults aged 40-65 years with bilateral moderate to severe volume loss or contour deficiency (Facial Volume Loss Scale [FVLS] score: 2-5). Eligible subjects were treated at the baseline visit with an injection of hyaluronic acid gel in one or more of three facial subregions: the zygomatic malar region, the anteromedial cheek and nasolabial folds., Results: A significant improvement from baseline was observed in the FVLS score at each study visit up to 6 months post treatment (p < 0.0125 by Wilcoxon test). A significant improvement was also observed in the Global Aesthetic Improvement Scale (GAIS) at each visit up to 6 months. The study showed that the GAIS score improved in 100% of subjects at month 3, while at the end of the study (month 6) the percentage of improved subjects decreased to 91. Treatment effect was maintained by 100% of subjects up to month 3, while 57% of subjects showed a persistence of effect up to month 6., Conclusions: Volume loss or contour deficiency may be safely and effectively corrected using the new dermal filler.

Background: A novel Hyaluronic Acid (HA) derivative dermal filler has been developed with characteristics especially suited for nasolabial folds (NLF) and facial defects due to volume loss., Aims: An open-label prospective study was carried out to evaluate this HA filler's performance in correcting facial defects due to volume loss., Methods: A single Italian site treated subjects aged 30-65 for facial defects due to volume loss with a new dermal filler injectable gel; subjects returned to the clinic at 7 and 14 days, and 1, 3, 6, 9, and 12 months for follow-up. The primary effectiveness endpoint was improvement in wrinkle severity (measured using the Wrinkle Severity Rating Scale) (WSRS) and facial volume (measured using the Facial Volume Loss Scale) (FVLS) at 6 and 12 months from baseline. Secondary endpoints were safety evaluation, performance duration, product handling, subjects' and investigator's treatment evaluation. Assessment of aesthetic results included the skin hydration, image analysis of nasolabial folds (3D), and photographic documentation., Results: The reduction in nasolabial wrinkles was statistically significant at 6 months after the first implant. The aesthetic improvement of 1 grade on WSRS was evident in 95% of subjects up to 3 months, in 84% of subjects up to 6 months and in 27% up to 12 months. A clinically (> 1 point improvement) and statistically significant improvement in the FVLS was observed at each study visit; in 100% of treated cases, up to 3 months and in 61% up to 9 months. Good results were obtained during the study in skin hydration. There were no severe adverse events related to treatment., Conclusion: This injectable gel is well tolerated and has been demonstrated to provide a smooth and natural improvement in facial defects due to volume loss in nasolabial folds and the malar region that lasts for up to 1 year., (© 2014 Wiley Periodicals, Inc.)

Introduction: Atrophic vaginitis is a common occurrence, particularly among postmenopausal women; however, few seek or receive treatment. One therapeutic solution is topically applied products. Estrogen-based treatments have been shown to be effective; however, many patients are reluctant to use such formulations due to health concerns, hence the need to assess the efficacy of acceptable alternatives., Aim: This multicenter, randomized, controlled, open-label, parallel-group clinical trial set out to evaluate the efficacy and safety of hyaluronic acid vaginal gel to treat vaginal dryness compared with estriol cream in postmenopausal women., Methods: One hundred forty-four subjects were randomized, 72 to the test group treated with hyaluronic acid vaginal gel (Hyalofemme) and 72 to the control group treated with estriol cream (Ovestin). Treatment in both groups was applied by means of a device once every 3 days for a total of 10 applications over 30 days., Main Outcome Measures: Efficacy was measured by grading vaginal dryness and three other vaginal symptoms on a visual analog scale. Safety assessments included vital signs, laboratory examinations of the vaginal microecosystem, vaginal pH value, vaginal B ultrasound, and incidence of adverse events. Assessments were performed at baseline, by telephone after the third application, and at the final visit., Results: Both hyaluronic acid vaginal gel and estriol cream can significantly improve the clinical symptoms of vaginal dryness in postmenopausal women, with improvement rate of 84.44% and 89.42%, respectively, after 10 applications, without statistically significant difference between them., Conclusion: Both hyaluronic acid vaginal gel and estriol cream are effective in the treatment of vaginal dryness. Hyaluronic acid vaginal gel may be considered as a valid alternative to estrogen-based treatments in relieving the symptoms of vaginal dryness., (© 2013 International Society for Sexual Medicine.)

Background: Clinical trials have demonstrated the safety and efficacy of hyaluronic acid-based products for the treatment of synovial joints affected by osteoarthritis (OA), but data from observational studies of normal medical practice are sparse., Aim: This study investigated the safety and efficacy of intra-articular (IA) sodium hyaluronate (MW 1500-2000 KDa; Hyalubrix®) in the treatment of synovial joint OA., Design: This is prospective, and observational study., Setting: This study was carried out at 47 specialist centers for physiatrists, orthopedics and rheumatology in Italy; the enrolled population, 1266 outpatient, was predominantly female (66%, 840/1266), with a mean age of 66 years, and a mean weight of 74 kg., Population: The Participants with OA received IA injections of the study treatment (2 mL) once per week for 3 weeks. The knee was the joint most commonly affected by OA (right knee 802/1266 [63%]; left knee 598/1266 [47%]), and the longest median duration of disease occurred in the carpal joint (right carpal joint 40 months; left carpal joint 60 months)., Methods: The primary endpoints were tolerability and details of usage of the IA sodium hyaluronate syringe device. Efficacy parameters included assessment of self-reported pain via the Visual Analogue Scale (VAS), and evaluation of motor function via the Health Assessment Questionnaire (HAQ). Quality of life (QoL) was assessed using the Euro QoL questionnaire (Clinical Trial Registration Number: ISRCTN 42690497)., Results: Data from 1266 participants were collected. The adverse event (AE) rate was 0.8% (95% CI, 0.4 to 1.5). Thirteen AEs were reported, 12 of which were mild or moderate in severity. Only one participant discontinued study treatment following an AE. No serious adverse events occurred. Coadministration of local anesthetic was required by up to 10% of patients. Statistically significant improvements in VAS, HAQ and EuroQoL were recorded in multiple joints (P<0.0001 for each)., Conclusion: The study treatment was safe and well tolerated., Clinical Rehabilitation Impact: . The study treatment reduced pain, improved mobility, and increased QoL in participants with OA.