Gel In Patients Research Articles

Updated long-term safety from ongoing phase 3 trials of levodopa-carbidopa intestinal gel in patients with advanced Parkinson's disease

Updated long-term safety from ongoing phase 3 trials of levodopa-carbidopa intestinal gel in patients with advanced Parkinson's disease

Updated long-term safety from ongoing phase 3 trials of levodopa-carbidopa intestinal gel in patients with advanced Parkinson's disease

Objectives: To summarize the integrated long-term safety data of levodopa-carbidopa intestinal gel (LCIG/carbidopa-levodopa enteral suspension [CLES]) from four ongoing phase 3 studies through 31 March 2014.

Transcutaneous port for levodopa/carbidopa intestinal gel administration in Parkinson's disease.

To evaluate the safety and tolerability of the T-Port(®) for intestinal infusion of levodopa/carbidopa gel in patients with advanced Parkinson's disease (PD). This prospective study was carried out in 24 patients with PD (15 males, mean age 61.8 years, mean duration PD 18.7 years). All adverse device effects were evaluated at 2 weeks, 3 months and 6 months and until explantation or death. Post-operative complications were similar to endoscopic gastrojejunostomy placement (four peritoneal irritation, one pocket pain). Eight patients with prior experience with the endoscopic gastrojejunostomy preferred the T-Port. The total device experience was 83.6 years, and the average survival time was 3.6 (range 1.1-5.2) years. Six T-Ports were still in use, and two patients had died due to non-device-related reasons. Sixteen T-Ports had been explanted due to 15 stoma reactions (14 inflammations and one infection) and one tilting of the T-Port. The T-Ports were replaced with endoscopic gastrojejunostomy system as replacements with T-Ports were not part of the study. Only two device malfunctions occurred (one catheter breakage at 3 year post-implant and one T-Port leakage of levodopa/carbidopa gel). No tube kinking, dislocation or blockage occurred. The number of adverse device effects proved to be significantly lower as compared to the endoscopic gastrojejunostomy literature data. The T-Port is safe and well tolerated, and the low number of tube problems is a potential advantage compared with the endoscopic gastrojejunostomy system. Proper cleaning and local treatment of the stoma site around the T-Port are essential to prolong its longevity.

Long-term response to continuous duodenal infusion of levodopa/carbidopa gel in patients with advanced Parkinson disease: The Barcelona registry.

Continuous infusion of levodopa/carbidopa intestinal gel (LCIG) is an effective treatment for patients with advanced Parkinson Disease (PD) that cannot be further improved by oral therapy. We conducted an observational, prospective, and multicenter study to collect, in a large sample of PD treated with LCIG, long-term information about the outcome and safety of the treatment. The assessments were performed before LCIG, 1, 3, 6 months after, and ever since, every 6 months. We studied 72 patients with a mean observation time of 22 months and a maximum of 48 months. During follow-up 28 patients discontinued the treatment, especially for lack of efficacy or adverse events related to the drug. We obtained a significant improvement of motor and non-motor fluctuations, mean off time and some non-motor symptoms. A significant increase in the percentage of time with dyskinesias was found in patients having less than 50% of the day with dyskinesias before LCIG. However, patients having already many dyskinesias before LCIG experienced a significant decrease of the troublesome dyskinesias, meaning that outcomes might be different depending on specific clinical characteristics. Adverse effects were in general minor but one case of intestinal perforation and one of abdominal cellulite were observed. We confirmed that LCIG is a very effective treatment option for advanced PD; however considering the findings that dyskinesia can increase and the potential for serious side effects, we suggest the necessity for development of guidelines that better define the profile of responders.

Global Long-Term Registry on Efficacy and Safety of Levodopa-Carbidopa Intestinal Gel in Patients with Advanced Parkinson’s Disease in Routine Care (GLORIA) - Interim Results on Non-Motor Symptoms (I3-3B)

Global Long-Term Registry on Efficacy and Safety of Levodopa-Carbidopa Intestinal Gel in Patients with Advanced Parkinson’s Disease in Routine Care (GLORIA) - Interim Results on Non-Motor Symptoms (I3-3B)

Global Long-Term Registry on Efficacy and Safety of Levodopa-Carbidopa Intestinal Gel in Patients with Advanced Parkinson’s Disease in Routine Care (GLORIA) - Interim Results on Non-Motor Symptoms (P3.004)

Global Long-Term Registry on Efficacy and Safety of Levodopa-Carbidopa Intestinal Gel in Patients with Advanced Parkinson’s Disease in Routine Care (GLORIA) - Interim Results on Non-Motor Symptoms (P3.004)

Global Long-term Registry on Efficacy and Safety of Levodopa-Carbidopa Intestinal Gel in Patients with Advanced Parkinson’s Disease in Routine Care (GLORIA) - Interim Results in a Subgroup of Patients with Dyskinesia at Baseline (P1.192)

Global Long-term Registry on Efficacy and Safety of Levodopa-Carbidopa Intestinal Gel in Patients with Advanced Parkinson’s Disease in Routine Care (GLORIA) - Interim Results in a Subgroup of Patients with Dyskinesia at Baseline (P1.192)

A dermocosmetic containing bakuchiol, Ginkgo biloba extract and mannitol improves the efficacy of adapalene in patients with acne vulgaris: result from a controlled randomized trial.

BackgroundAcne vulgaris is an inflammatory disorder of the pilosebaceous unit.AimTo confirm that BGM (bakuchiol, Ginkgo biloba extract, and mannitol) complex increases the established clinical efficacy of adapalene 0.1% gel in patients with acne.MethodsA clinical trial was conducted in acne patients. A total of 111 subjects received adapalene 0.1% gel and BGM complex or vehicle cream for 2 months. Assessments comprised Investigator Global Assessment (IGA), global efficacy, seborrhea intensity, inflammatory and non-inflammatory lesions, and subject perception, as well as overall safety and local tolerance and quality of life.ResultsAt the end of the trial, inflammatory and non-inflammatory lesions, IGA, global efficacy, and seborrhea intensity had significantly improved in both treatment groups. Differences were statistically significant (P<0.05) in favor of BGM complex for inflammatory lesions as well as IGA and seborrhea intensity. Global efficacy assessments and subject perception confirmed the superiority of BGM complex-including treatment over the comparative combination. Quality of life had improved more with the active combination than with the vehicle combination. In the active group, four subjects had to interrupt temporarily BGM complex and 12 adapalene compared to seven subjects interrupting the vehicle and eleven adapalene in the vehicle group. One subject withdrew from the trial due to an allergy to adapalene. The majority of all events were mild.ConclusionBGM complex improves the treatment outcome of adapalene 0.1% gel in patients with acne vulgaris. Overall, safety and local tolerance of BGM complex were good.

Efficacy and Safety of a Lidocaine Gel in Patients from 6 Months up to 8 Years with Acute Painful Sites in the Oral Cavity: A Randomized, Placebo-Controlled, Double-Blind, Comparative Study.

Lidocaine is a well-accepted topical anaesthetic, also used in minors to treat painful conditions on mucosal membranes. This randomized, double-blind, placebo-controlled study (registered prospectively as EudraCT number 2011-005336-25) was designed to generate efficacy and safety data for a lidocaine gel (2%) in younger children with painful conditions in the oral cavity. One hundred sixty-one children were included in two subgroups: 4–8 years, average age 6.4 years, treated with verum or placebo and 6 months–<4 years, average age 1.8 years, treated only with verum. Pain reduction was measured from the time prior to administration to 10 or 30 minutes after. In addition, adverse events and local tolerability were evaluated. In group I, pain was reduced significantly after treatment with verum compared to placebo at both time points. In group II, the individual pain rating shift showed statistically significant lower pain after treatment. Only seven out of 161 patients reported an adverse event but none were classified as being related to the study medication. The local tolerability was assessed as very good in over 97% of cases. For painful sites in the oral cavity, a 2% lidocaine gel is a meaningful tool for short-term treatment in the paediatric population.

THE EFFICACY AND SAFETY OF CARMOLIS GEL IN THE COMBINATION THERAPY OF KNEE OSTEOARTHRITIS: RESULTS OF A MULTICENTER CLINICAL TRIAL

Osteoarthritis (OA) is one of the most common rheumatic diseases. Knee OA is particularly frequently encountered among all forms of OA, the prevalence of knee OA being about 25% in the general population. Despite multiple guidelines for the management of knee OA, which have been prepared by the European League Against Rheumatism (EULAR), the American College of Rheumatology (ACR), and the Osteoarthritis Research Society International (OARSI), many problems of its treatment policy remain to be solved. The same holds true for not only the symptomatic and disease-modifying effects of chondroprotectors, but also topical therapy options. Objective : to evaluate the clinical efficacy and safety of Carmolis gel in patients with knee OA. Subjects and methods. The trial included 280 patients with knee OA (a study group consisted of 190 patents; a control group comprised 90 patients). The mean age was 58.3±9.3 years in the study group and 59±10.5 years in the control group. The disease duration was 10.3±5.5 and 10.1±4.1 years, respectively. Carmolis gel was applied to the region of the most painful knee joint up to 4–5 times daily, followed by massage of this skin area. The treatment cycle lasted for 2 weeks. No therapy was performed in the control patients. The clinical efficacy was determined by the changes in joint pains at rest or on movement and palpation, according to a visual analogue scale (VAS), WOMAC questionnaire, the synovitis intensity (assessed by ultrasonography), patient and physician global assessments of disease activity (Likert scale), and the possibility of reducing the daily dosage of nonsteroidal anti-inflammatory drugs (NSAIDs). The onset the therapeutic effect of the gel and the duration of its action were recorded. Results and discussion. The topical application of Carmolis gel caused a statistically significant reduction in joint pain at rest and on movement from 57.7±6.8 to 12±1.8 mm (р < 0.01) and from 52±5.3 to 17±2.7 mm, respectively (р<0.01). The WOMAC showed similar pain changes. In the study group, the WOMAC pain level averaged 210±20.5 mm at baseline and reduced to 101±12.8 mm after the treatment (p < 0.01).The control group also exhibited pain relief, but to a much lesser degree than did the study group. There were no statistically significant differences between the groups in motor and day-to-day activity changes. After treatment, the patients of both groups had reduction in the signs of synovitis; however, no differences were found between the groups. The dose of NSAIDs could be decreased in 99 (52.1%) of the 190 patients in the study group and only in 15 (16.6%) of the 90 patients in the control group (p<0.05). Carmolis gel was well tolerated. No adverse events were observed in 184 patients. Local cutaneous reactions and itch were noted in 6 (3.2%) patients; however, they were short-term and did not required drug discontinuation. Conclusion. The findings suggest that the incorporation of Carmolis gel into the combination therapy of OA ensures a significant reduction in joint pain and allows the dose of NSAIDS to be decreased, making the treatment safer.

Comparative pharmacokinetics and bioavailability of brimonidine following ocular and dermal administration of brimonidine tartrate ophthalmic solution and gel in patients with moderate-to-severe facial erythema associated with rosacea

Persistent facial erythema is the most common primary pathological feature of rosacea, the only treatment for which is brimonidine tartrate (BT) gel. To assess the relative bioavailability of topical BT gel in comparison with the ophthalmic BT solution. A pharmacokinetic study was conducted to compare intraindividual systemic exposures after dermal application of BT gel (0·07%, 0·18% and 0·5%) under maximal use conditions in patients with moderate-to-severe facial erythema associated with rosacea, and administration of BT ophthalmic solution 0·2%. Patients who received BT ophthalmic solution 0·2% three times a day for 1 day had a mean Cmax of 54 ± 28 pg mL(-1) and a mean 0-24-h area under the curve (AUC0-24 h ) of 568 ± 277 pg h mL(-1) . Topical application of BT gel for 29 days resulted in quantifiable systemic exposure in 22%, 48%, 71% and 79% of patients who received BT gel 0·07% twice daily, 0·18% once daily, 0·18% twice daily and 0·5% once daily, respectively. The mean Cmax values for the BT gels ranged between 13 and 25 pg mL(-1) , and mean AUC0-24 h values ranged between 42 and 290 pg h mL(-1) . Systemic exposure increased with applied dose, with no drug accumulation for the duration of treatment. The systemic exposure observed with the highest dose of BT gel (0·5% once daily) was significantly lower than the systemic levels observed for the ophthalmic solution. 0·2% apply for all the concentrations. The systemic safety profile of BT gel may be considered better than that of the ophthalmic solution.

Employment of autologous platelet gel in patients with skin ulcers correlated to the phenomenon of Raynaud

Employment of autologous platelet gel in patients with skin ulcers correlated to the phenomenon of Raynaud

Safety Analyses from Open-Label Clinical Trials of Levodopa-Carbidopa Intestinal Gel in Patients with Advanced Parkinson’s Disease: Events Not Related to Device or Procedure (P7.083)

Safety Analyses from Open-Label Clinical Trials of Levodopa-Carbidopa Intestinal Gel in Patients with Advanced Parkinson’s Disease: Events Not Related to Device or Procedure (P7.083)

Preoperative Evaluation of Lower Rectal Cancer by Pelvic MR with and without Gel Filling

Purpose : To assess the usefulness of rectal filling using ultrasonographic gel in patients with lower rectal cancer. Materials and Methods: Twenty five patients with lower rectal cancer were enrolled. High resolution pelvic MR was performed twice before and after gel filling. Independently and retrospectively, two radiologists reviewed each set of MR images using five-grade scales for sphincter involvement, CRM (circumferential resection margin) involvement and depiction of the tumor. Same two radiologists retrospectively performed consensus review of each set of MR images for tumor distance from the anal verge and T&N staging. Results: Tumor depiction scores from MR with gel filling were significantly higher than those of MR without distention (p 0.05). Distance from the anal verge was significantly different between MR with gel filling and rigid endoscopy (6.8 1.6 cm vs. 5.8 1.6 cm, p=0.001). There were no significant differences between pathological staging and MR staging with or without gel filling. Conclusion: MR with gel filling improved tumor depiction. And also MR with gel filling revealed same ability for the predictions of CRM or sphincter invasion in patients with lower rectal cancer, comparing with MR without gel filling. Index words : Rectal cancer∙Magnetic resonance imaging (MRI)∙Rectum∙Ultrasonographic transmission gel Preoperative staging

Topical Delivery of Lipid Based Amphotericin B Gel in the Treatment of Fungal Infection: A Clinical Efficacy, Safety and Tolerability Study in Patients

Objectives: A novel topical formulation of lipid based amphotericin B (0.1% amphotericin B Gel) was developed to assess the safety, tolerability and efficacy in adult patients with cutaneous and/or mucocutaneous fungal infection. Methods: Amphotericin B gel was formulated using lipids. In vitro release assay of amphotericin B was measured using paddle apparatus maintained at 37.0° ± 0.5°C. The stability studies of amphotericin B gel were carried out at 2-8°C, 25°C and 40°C. To test the effect of the drug in clinical setting, 100 patients with recurrent case after failure to standard therapy for cutaneous and/or mucocutaneous fungal infection were treated with amphotericin B Gel. The amphotericin B Gel was applied on the affected area twice daily for 14 days in patients with cutaneous fungal infection and for 7 days in patients of mucocutaneous fungal infection. Response to the amphotericin B Gel treatment was monitored in the patients for up to 14 days and 28 days for mucocutaneous and cutaneous infection respectively. Results: Based on the stability studies, the recommended shelf life of amphotericin B gel is 24 months at 25°C. In vitro studies showed the release of ~90% amphotericin B within two hours and complete release within four hours. A total of 83 patients were assessed for cutaneous fungal infection where 39 patients were cured, 9 patients showed marked improvement, 26 patients showed moderate improvement and 9 patients showed failure after the treatment. For mucocutaneous fungal infection, 100% patients were cured at the end of the treatment. No serious adverse events were reported in patients during the study. Conclusion: Lipid based amphotericin B gel in patients with cutaneous and mucocutaneous fungal infections was found to be safe, tolerable and efficacious.

Prospective Evaluation of Office-Based Injection Laryngoplasty with Hyaluronic Acid Gel

The role of Juvederm Ultra Plus hyaluronic acid gel for use in injection laryngoplasty has not been well examined. The aim of this study was to prospectively assess the safety and clinical effectiveness of office-based injection laryngoplasty of Juvederm Ultra Plus gel in patients with glottic insufficiency. Thirty patients met the criteria for study inclusion and were treated with unsedated office-based injection laryngoplasty of Juvederm Ultra Plus gel over a 20-month period. The preinjection acoustic and aerodynamic measures, Voice Handicap Index, Glottal Function Index, and Dysphonia Severity Index were compared with values recorded at 1 and 4 months after injection. Data for 27 patients were available for follow-up analysis at 1 month, and 12 patients' data were available at 4 months. Significant improvements, compared to preinjection levels (p < 0.02), were shown in all outcome measures at 1 and 4 months. One patient required intravenous steroid therapy for delayed glottic inflammation that resolved without permanent sequelae. The injection of Juvederm Ultra Plus gel is a relatively safe procedure that allows for short-term improvements in objective and subjective outcome measures of vocal function in patients with glottic insufficiency, provided the surgeon remains alert to the possibility of postprocedural injection site inflammation.

Effectiveness of sodium hyaluronate eye gel in patients with dry eye disease: A multi-centre, open label, uncontrolled study

To assess the effectiveness of sodium hyaluronate Eye Gel in Dry Eye Disease (DED) patients Methods: A Multi-center, Open-label, Uncontrolled clinical trial was conducted in different centers of Pakistan. Ten ophthalmologists conducted this study in which 250 diagnosed patients with dry eye disease were enrolled after obtaining a written informed consent. Ten patients were dropped out during the study period. All patients were assessed as per following criteria for enrolling a patient into the study: Tear Film Break - up time (TBUT) ≤ 10 seconds, Schirmer Test - 1 ≤ 6 mm / 5 minutes and Positive Corneal Staining. Tolerability/safety was assessed by the monitoring and recording of all adverse events. The physical examination was done at baseline, 4(th) week and 8(th) week. Results : The mean age of the patients was 43.4 ±17.8 years and out of 240 patients 117 (48.7%) were males and 123 (51.3%) females. The Mean duration of symptoms was 19.3±23.9. At the initial visit the foreign body sensation was 50.6%, itching 35.9%, burning 50.6%, watering 42.9%, photophobia 25.3% and feeling of dryness in 14.7% of patients. After 4 weeks (2(nd) visit), the symptoms were decreased to 47.1% foreign body sensation, 32.4% itching, 48.2% burning, 41.8% watering, 25.3% photophobia and 13.5% feeling of dryness. At the 3(rd) visit (after 8 weeks) the frequency of symptoms were: 45.3% foreign body sensation, 30.6% itching, 45.9% burning, 40% watering, 24.7% photophobia and 13.5% feeling of dryness. Sodium Hyaluronate can provide a suitable alternate in the treatment of dry eye disease due to its reported efficacy on foreign body sensation, itching, burning, watering, photophobia and feeling of dryness.

Clinical and bacteriological evaluation of adapalene 0.1% gel plus nadifloxacin 1% cream versus adapalene 0.1% gel in patients with acne vulgaris

This multicenter, randomized parallel group study investigated the efficacy and tolerability of adapalene 0.1% gel plus nadifloxacin 1% cream (combination therapy) compared with adapalene gel (monotherapy) during 12-week treatment of acne vulgaris. A total of 184 Japanese patients aged above 12years with moderate to severe acne as indicated by the Japanese severity grading criteria were randomized to combination therapy (n=84) and monotherapy (n=100) groups, both having comparable demographic and baseline characteristics. Adapalene was applied only to inflammatory acne lesions in order to minimize skin irritation and ensure the treatment results. Efficacy and safety evaluations, treatment compliance and satisfaction with drug application were periodically monitored. The combination therapy provided a significantly greater efficacy than adapalene in decrement of inflammatory papulopustular lesions at 4weeks and thereafter (P=0.0056). The overall judgment of the therapeutic efficacy by the physician at the end of study revealed a significant difference (P=0.02496) between the groups in favor of combination therapy. Dryness was reported in a greater proportion of patients undergoing monotherapy than combination therapy at weeks 2 and 4 (P=0.04652). The patient self-assessment in satisfaction with the drug application at the end of study revealed a significant difference (P=0.00268) between the groups in favor of combination therapy. Among 76 strains of Propionibacterium acnes isolated from 87 patients, no strain was resistant to nadifloxacin. Thus, the simultaneous use of adapalene and nadifloxacin may provide an additive and complementary effect, resulting in clinical superiority and greater patient adherence compared to adapalene monotherapy.

Effectiveness of a novel topical anesthetic gel in patients undergoing non surgical periodontal therapy.

800x600 Objectives: To evaluate the efficacy of a topical anesthetic gel containing potassium nitrate, benzocaine and tetracaine in patients undergoing non surgical periodontal therapy. Materials and Methods: The present study was a randomised, double blind, placebo controlled, split mouth design trial carried out in 300 patients. Two quadrants in each patient were selected for non surgical periodontal therapy. The drug gel and placebo were liberally applied over the teeth and gingiva on the selected quadrants and the treatment was started after two minutes. Patients were asked to evaluate their pain experience at the end of treatment of their respective quadrants using verbal rating scale. Results: The mean pain score on using the drug gel was 0.433+0.737 as compared to the mean pain score of 2.35+0.761 on using the placebo gel, and the results were statistically significant. The drug gel out performed the placebo gel. None of the patients reported of any local or systemic side effects. Conclusions: The topical anesthetic gel provided excellent pain control for the patients undergoing non surgical periodontal therapy. It can also be considered as a good option during periodontal examination and maintenance visits to increase the patients comfort. Normal 0 21 false false false TR X-NONE X-NONE MicrosoftInternetExplorer4 /* Style Definitions */ table.MsoNormalTable {mso-style-name:Normal Tablo; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-parent:; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin:0cm; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:Calibri,sans-serif;}

A metaanalysis to investigate the relationship between Fitzpatrick skin types and tolerability of adapalene–benzoyl peroxide topical gel in patients with mild or moderate acne

A metaanalysis to investigate the relationship between Fitzpatrick skin types and tolerability of adapalene–benzoyl peroxide topical gel in patients with mild or moderate acne